DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Center - WO66-G609
`Silver Spring, MD 20993-0002
`
`October 21, 2016
`
`BTL Industries, Inc.
`Jan Zarsky
`Director
`47 Loring Drive
`Framingham, Massachusetts 01702
`
`Re: K160992
`Trade/Device Name: HPM-6000
`Regulation Number: 21 CFR 890.5850
`Regulation Name: Powered Muscle Stimulator
`Regulatory Class: Class II
`Product Code: IPF
`Dated: March 21, 2016
`Received: April 8, 2016
`
`Dear Jan Zarsky:
`
`We have reviewed your Section 510(k) premarket notification of intent to market the device
`referenced above and have determined the device is substantially equivalent (for the indications
`for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
`commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
`devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
`and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
`You may, therefore, market the device, subject to the general controls provisions of the Act. The
`general controls provisions of the Act include requirements for annual registration, listing of
`devices, good manufacturing practice, labeling, and prohibitions against misbranding and
`adulteration. Please note: CDRH does not evaluate information related to contract liability
`warranties. We remind you, however, that device labeling must be truthful and not misleading.
`
`If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
`it may be subject to additional controls. Existing major regulations affecting your device can be
`found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
`publish further announcements concerning your device in the Federal Register.
`
`Please be advised that FDA's issuance of a substantial equivalence determination does not mean
`that FDA has made a determination that your device complies with other requirements of the Act
`or any Federal statutes and regulations administered by other Federal agencies. You must comply
`with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
`Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
`related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
`
`LUMENIS EX1021
`Page 1
`
`

`

`Page 2
`
`- Jan Zarsky
`
`the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
`radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
`contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
`or (301) 796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
`the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
`807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
`CFR Part 803), please go to
`http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
`of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`You may obtain other general information on your responsibilities under the Act from the
`Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
`796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
`
`Sincerely yours,
`
`William J.
`Heetderks -A
`
`Digitally signed by William J. Heetderks -
`A
`DN: c=US, o=U.S. Government, ou=HHS,
`ou=NIH, ou=People,
`0.9.2342.19200300.100.1.1=0010149848,
`cn=William J. Heetderks -A
`Date: 2016.10.21 16:12:18 -04'00'
`
`for
`
`Carlos L. Peña, PhD, MS
`Director
`Division of Neurological
`and Physical Medicine Devices
`Office of Device Evaluation
`Center for Devices and Radiological Health
`
`Enclosure
`
`LUMENIS EX1021
`Page 2
`
`

`

`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`Food and Drug Administration
`Indications for Use
`
`Form Approved: OMB No. 0910-0120
`Expiration Date: January 31, 2017
`See PRA Statement below.
`
`510(k) Number (if known)
`K160992
`
`Device Name
`HPM-6000
`
`Indications for Use (Describe)
`The HPM-6000 device is intended to be used under medical supervision for adjunctive therapy for the treatment of
`medical diseases and conditions.
`
`The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or
`arms for rehabilitative purposes.
`
`Indications for Use for Muscle Stimulators:
`• Relaxation of muscle spasms
`• Prevention or retardation of disuse atrophy
`• Increasing local blood circulation
`• Muscle re-education
`• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
`• Maintaining or increasing range of motion
`
`Type of Use (Select one or both, as applicable)
`Prescription Use (Part 21 CFR 801 Subpart D)
`
`Over-The-Counter Use (21 CFR 801 Subpart C)
`
`CONTINUE ON A SEPARATE PAGE IF NEEDED.
`
`This section applies only to requirements of the Paperwork Reduction Act of 1995.
`*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
`The burden time for this collection of information is estimated to average 79 hours per response, including the
`time to review instructions, search existing data sources, gather and maintain the data needed and complete
`and review the collection of information. Send comments regarding this burden estimate or any other aspect
`of this information collection, including suggestions for reducing this burden, to:
`Department of Health and Human Services
`Food and Drug Administration
`Office of Chief Information Officer
`Paperwork Reduction Act (PRA) Staff
`PRAStaff@fda.hhs.gov
`“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`information unless it displays a currently valid OMB number.”
`
`FORM FDA 3881 (8/14)
`
`Page 1 of 1
`
`PSC Publishing Services (301) 443-6740 EF
`
`LUMENIS EX1021
`Page 3
`
`

`

`510(k) Summary
`K160992/S001
`
`
`
`General Information
`
`Sponsor:
`
`
`
`
`
`Applicant:
`
`
`
`
`
`Contact Person:
`
`
`
`
`Summary Preparation
`Date:
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`Jan Zarsky
`Director
`BTL Industries, Inc.
`zarskyj@btlnet.com
`
`October 21, 2016
`
`
`
`Device Name
`Trade/Proprietary Name:
`Primary Classification Name:
`Classification Regulation:
`Classification Product Code:
`
`HPM-6000
`Stimulator, Muscle, Powered
`21 CFR 890.5850, Class II
`IPF
`
`Legally Marketed Predicate Devices
`The HPM-6000 is a state-of-the-art magnetic device with accessories, and is substantially
`equivalent to its predicate that is already cleared for distribution in the USA under the
`following 510(k) Premarket Notification number:
`
`LUMENIS EX1021
`Page 4
`
`

`

`• Neotonus MS-101 Magnetic Muscle Stimulator System (K973929)
`
`Product Description
`The HPM-6000 is a non-invasive therapeutic device. The device produces electromagnetic
`field that interacts with the tissues of the human body, while mainly affected structures are
`muscular, collagenous, and neuronal tissue. The electromagnetic field is delivered in the
`subdermal, muscular or collagenous tissue area triggering the stimulation and relaxation. The
`subject device does not use electroconductive media.
`
`The HPM-6000 is equipped with a color touch screen with wide view angle that significantly
`facilitates the use of the device. The on-screen information guides the user step-by-step
`through the entire therapy procedure. The therapeutic parameters are easily set using the
`touch screen, buttons and knob on the device. During the therapy the device keeps
`information about the applied therapy type, remaining therapy time and main therapy
`parameters on the screen.
`
`Intended Use
`The HPM-6000 device is intended to be used under medical supervision for adjunctive
`therapy for the treatment of medical diseases and conditions.
`
`The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk
`muscle excitation in the legs or arms for rehabilitative purposes.
`
`Indications for Use for Muscle Stimulators:
`• Relaxation of muscle spasms
`• Prevention or retardation of disuse atrophy
`•
`Increasing local blood circulation
`• Muscle re-education
`•
`Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
`• Maintaining or increasing range of motion
`
`Non-clinical Testing
`The HPM-6000 device has been thoroughly evaluated for electrical safety. The HPM-6000
`has been found to comply with the following applicable medical device safety standards:
`ISO 14971
`Medical devices – Application of risk management to medical devices
`IEC 62304
`Medical device software – Software life cycle processes
`IEC 60601-1
`Medical electrical equipment – Part 1: General requirements for basic
`safety and essential performance
`IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for
`basic safety and essential performance - Collateral standard:
`Electromagnetic compatibility – Requirements and tests
`
`LUMENIS EX1021
`Page 5
`
`

`

`IEC 62366
`
`ISO 10993-1
`
`ISO 10993-5
`
`IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
`basic safety and essential performance – Collateral standard: Usability
`Medical devices - Application of usability engineering to medical
`devices
`Biological evaluation of medical devices – Part 1: Evaluation and
`testing within a risk management process
`Biological evaluation of medical devices – Part 5: Tests for in vitro
`cytotoxicity
`Biological evaluation of medical devices – Part 10: Tests for irritation
`and skin sensitization
`
`ISO 10993-10
`
`Clinical testing
`The substantial equivalence determination for the HPM-6000 is not based on clinical testing.
`The device safety and efficacy was demonstrated by performance data and comparison of
`technical characteristics between the HPM-6000 and the predicate device.
`
`Summary of Clinical and Non-clinical testing
`Nonclinical test have been conducted to evaluate the HPM-6000 performance, and results
`confirm that the device performs as intended and in a similar manner compared to the
`predicate. Thus, the HPM-6000 is substantially equivalent to the predicate devices.
`
`Comparison with the Predicate Device
`
`510(k) number
`Device name
`
`
`Company name
`
`K160992
`HPM-6000
`
`
`BTL Industries, Inc.
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`
`Discussion
`
`Product Code
`and Regulation
`
`Intended Use
`
`Physical Medicine
`21 CFR 890.5850
`IPF – Stimulator, Muscle,
`Powered
`
`Physical Medicine
`21 CFR 890.5850
`IPF – Stimulator, Muscle,
`Powered
`
`The HPM-6000 device is
`intended to be used under
`medical supervision for
`adjunctive therapy for the
`treatment of medical diseases
`and conditions.
`The HPM-6000 device is
`indicated for use in stimulating
`neuromuscular tissue for bulk
`
`The Neotonus MS-101
`Magnetic Muscle Stimulator
`System is intended to be used
`under medical supervision for
`adjunctive therapy for the
`treatment of medical diseases
`and conditions.
`The Neotonus MS-101 is
`indicated for use in stimulating
`
`None
`
`None
`
`LUMENIS EX1021
`Page 6
`
`

`

`510(k) number
`Device name
`
`
`Company name
`
`Discussion
`
`K160992
`HPM-6000
`
`
`BTL Industries, Inc.
`muscle excitation in the legs
`or arms for rehabilitative
`purposes.
`
`Indications for Use for Muscle
`Stimulators:
`• Relaxation of muscle
`spasms
`• Prevention or retardation
`of disuse atrophy
`• Increasing local blood
`circulation
`• Muscle re-education
`• Immediate post-surgical
`stimulation of calf
`muscles to prevent
`venous thrombosis
`• Maintaining or increasing
`range of motion
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`neuromuscular tissue for bulk
`muscle excitation in the legs or
`arms for rehabilitative
`purposes.
`Indications for Use for Muscle
`Stimulators:
`• Relaxation of muscle
`spasms
`• Prevention or retardation
`of disuse atrophy
`• Increasing local blood
`circulation
`• Muscle re-education
`• Immediate post-surgical
`stimulation of calf
`muscles to prevent
`venous thrombosis
`• Maintaining or increasing
`range of motion
`
`Electrical
`Protection
`
`Class II, BF
`
`Class II
`
`Interface
`
`Touch-screen
`
`Graphical Display
`
`Type of Energy
`
`Magnetic field
`
`Magnetic field
`
`Type of
`Applicator
`
`Number of
`Magnetic Coils
`in the Applicator
`
`Number of
`Applicators
`
`Color Touch
`Screen
`
`Single magnetic coil
`
`Single magnetic coil
`
`1
`
`2
`
`8.4 in
`21.3 cm
`800×400 pixel
`
`1
`
`1
`
`Unknown
`
`Type of Operation Continuous
`
`Continuous
`
`Pulse Repetition
`Rate
`
`1 – 150 Hz
`
`1 – 55 Hz
`
`None
`
`Similar, not
`significantly
`different
`
`None
`
`None
`
`None
`
`None
`
`N/A
`
`None
`
`Similar
`Please see the
`discussion and
`
`LUMENIS EX1021
`Page 7
`
`

`

`510(k) number
`Device name
`
`K160992
`HPM-6000
`
`Company name
`
`BTL Industries, Inc.
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`
`Magnetic Field
`Intensity
`
`299-1 applicator: 0.5 – 1.8 T
`299-2 applicator: 0.7 – 2.5 T
`
`Up to 2.2 T
`
`Pulse Duration
`(±20 %)
`
`280 µs
`
`Pulse Amplitude
`
`0 – 100 %
`
`Therapy Time
`
`Up to 60 min
`
`Operating
`Temperature
`
`10–30 °C
`
` 275 µs
`
`0 – 100 %
`
`30, 60 min
`
`5–30 °C
`
`Operating
`Humidity
`
`30–75 %
`
`20–75 %
`
`Discussion
`
`conclusion
`below.
`
`Similar, not
`significantly
`different
`
`None
`
`None
`
`None
`
`Similar, not
`significantly
`different
`
`Similar, not
`significantly
`different
`
`Shape of
`Stimulation Pulse Sine, biphasic
`
`Sine, biphasic
`
`None
`
`Energy Source
`
`100 – 240 V AC, 50 – 60 Hz,
`max 14 A
`
`110 V AC, 50 – 60 Hz, 12 A
`
`None
`
`External
`Exchangeable
`Fuse
`
`Yes
`
`Yes
`
`None
`
`System
`Dimensions
`(W×H×D)
`
`500×970×580 mm
`
`500×580×230 mm
`
`(20×38×23 in)
`
`(20×23×9 in)
`
`System Weight
`
`33 kg (73 lb)
`
`28 kg (61 lb)
`
`Similar, not
`important for
`the device
`safety and
`effectiveness
`evaluation
`
`Similar, not
`important for
`the device
`safety and
`effectiveness
`evaluation
`
`LUMENIS EX1021
`Page 8
`
`

`

`510(k) number
`Device name
`
`K160992
`HPM-6000
`
`Company name
`
`BTL Industries, Inc.
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`
`Position
`
`Vertical – On castors
`
`Horizontal
`
`Discussion
`
`Similar, not
`important for
`the device
`safety and
`effectiveness
`evaluation
`
`The HPM-6000 device has the same indications for use and similar technological
`characteristics and principles of operation as its predicate device.
`
`One of the technological differences between the subject and predicate devices includes
`pulse repetition rate. Therefore, K952089, a powered muscle stimulator cleared under the IPF
`product code (predicate of the predicate or K952089) has been submitted to demonstrate that
`safety and effectiveness are not adversely affected. K952089 or Rich-Mar CM-II Muscle
`Stimulator has pulse repetition range rate of 2-200 Hz, compared to 0-150 Hz for HPM-6000,
`the subject device. The mechanism of action of the electrical stimulator and this kind of
`magnetic device is the same. The nerve gets stimulated by electrical current and while the
`method of delivery is the different (magnetic induction), it is still the same current delivered to
`the tissue that stimulates the nerve endings on a similar frequency.
`
`The technological differences between the HPM-6000 and predicate device, do not raise new
`types of safety or effectiveness questions.
`
`The non-clinical test results confirm that the depth of tissue penetration does not differ and
`pulse repetition rate works in a similar manner compared to the predicate. Thus, the HPM-
`6000 is substantially equivalent to the predicate devices.
`
`Substantial Equivalence
`Based upon the intended use and known technical information provided in this pre-market
`notification, the HPM-6000 device has been shown to be substantially equivalent to currently
`marketed predicate device.
`
`Conclusion
`Based on the aforementioned information, the HPM-6000 is safe and effective and
`substantially equivalent to the identified predicate device.
`
`LUMENIS EX1021
`Page 9
`
`

`

`
`
`www.archive.org
`
`415.561.6767
`
`415.840-0391 e-fax
`
`
`
`Internet Archive
`
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`_____________________
`
`
`
`AFFIDAVIT OF DUNCAN HALL
`
`
`
`1. I am a Records Request Processor at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`
`4. The archived data made viewable and browseable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). The date indicated by an extended URL applies
`to a preserved instance of a file for a given URL, but not necessarily to any other
`files linked therein. Thus, in the case of a page constituted by a primary HTML file
`and other separate files (e.g., files with images, audio, multimedia, design
`elements, or other embedded content) linked within that primary HTML file, the
`primary HTML file and the other files will each have their own respective extended
`URLs and may not have been archived on the same dates.
`
`6. Attached hereto as Exhibit A are true and accurate copies of screenshots of the
`Internet Archive's records of the archived files for the URLs and the dates specified
`in the attached coversheet of each printout.
`
`LUMENIS EX1021
`Page 10
`
`

`

`
`
`7. Attached hereto as Exhibit B are true and accurate copies of the Internet Archive's
`records of the archived files for the URLs and the dates specified in the attached
`coversheet of each file.
`
`8. I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Duncan Hall
`
`
`
`
`
`
`
`09/28/2021
`
`LUMENIS EX1021
`Page 11
`
`

`

`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`LUMENIS EX1021
`Page 12
`
`LUMENIS EX1021
`Page 12
`
`

`

`https://web.archive.org/web/20131106123126/http:/www.iskramedical.eu:80/magneto-
`therapy-medical/tesla-stym
`
`
`
`
`LUMENIS EX1021
`Page 13
`
`

`

`
`
`
`inteaver anenive—[http://www.iskramedical.eu/magneto-therapy-medical/tesla-stym |[[Go] AUG
`
`
`
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`UWaYBAChMMECIME15capures =ul uid
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`LUMENIS EX1021
`Page 14
`
`LUMENIS EX1021
`Page 14
`
`

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`Noninvasive and painless method
`Easyto reach every part of the body
`Magnetic field strength up to 1,5 Tesla
`Possibility of fixing the applicator
`
`Brochure:S{2ENG | geeSLO! SEHR
`
`Howdoes a magnetic field activate a muscle?
`
`Rapid changes of magnetic field intensity induce an electrical currentin the neuron. This phenomenonis called electromagnetic induction. Once the currentreaches a certain
`value, a so-called neuron action potential is achieved. This causes the neuroncell to depolarize, which eventually leads to a complete muscle contraction.
`
`Whatare the advantages of TESLA Stym FMS,Functional Magnetic Stimulation?
`
`FMSallowsstimulation of deep muscle structures that cannot be reached by FES
`FMSeffectively stimulates muscle tissue without direct skin contact
`FMSispainless, noninvasive and thussuitable for patients where FES cannot be used
`The applicator can be fixed to the body or the therapist can perform therapy manually
`Manually moving the applicator allows motorunits to be found easily, enabling effective stimulation
`Nonegative side effects are knownin theliterature as long as contraindications are taken into account
`
`Indications:
`
`* Musculoskeletal disorders: degenerative arthritis, rheumatoid arthritis, cervical pain, muscle pain
`* Spinal disorders: acute/chronic lumbago, hip gout (sciatica), spina bifida, spondylitis
`* Nerve disorders: peripheral nerve damage
`* Muscle relaxation, frozen shoulder
`* Nerve or musclerehabilitation after fractures
`* Pain control for muscle atrophy, spasm, ankylosis
`* Genitourinary diseases: prostate pain
`* Acute pain control
`* Sports injuries
`
`BASIC SET:
`
`
`1 pe
`- Applicator FMSlarge (1511306)
`1 pe
`- Applicator FMS small (1511305)
`- Fixing rubberstrap 3,2 x 100 cm (1504111) 2 pes
`- Fixingelastic strap 10 x 80 cm (1504311)
`1 pe
`- Mains cable (230V, EURO plug)
`1 pe
`- User's Manual
`1 pe
`
`OPTIONS:
`
`
`- Trolley Green Eco (Code: 4900281)
`
`LUMENIS EX1021
`Page 15
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`LUMENIS EX1021
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`

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`LUMENIS EX1021
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`LUMENIS EX1021
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`EXHIBIT B
`EXHIBIT B
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`LUMENIS EX1021
`Page 17
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`LUMENIS EX1021
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`

`

`https://web.archive.org/web/20170430085613/https:/www.accessdata.fda.gov/cdrh_docs/pdf
`16/K163165.pdf
`
`
`
`
`LUMENIS EX1021
`Page 18
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`

`

`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Center - WO66-G609
`Silver Spring, MD 20993-0002
`
`February 16, 2017
`
`BTL Industries, Inc.
`David Chmel
`Director
`47 Loring Drive
`Framingham, Massachusetts 01702
`
`Re: K163165
`Trade/Device Name: AM-100
`Regulation Number: 21 CFR 890.5850
`Regulation Name: Powered Muscle Stimulator
`Regulatory Class: Class II
`Product Code: NGX
`Dated: January 16, 2017
`Received: January 17, 2017
`
`Dear Mr. Chmel:
`
`We have reviewed your Section 510(k) premarket notification of intent to market the device
`referenced above and have determined the device is substantially equivalent (for the indications
`for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
`commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
`devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
`and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
`You may, therefore, market the device, subject to the general controls provisions of the Act. The
`general controls provisions of the Act include requirements for annual registration, listing of
`devices, good manufacturing practice, labeling, and prohibitions against misbranding and
`adulteration. Please note: CDRH does not evaluate information related to contract liability
`warranties. We remind you, however, that device labeling must be truthful and not misleading.
`
`If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
`it may be subject to additional controls. Existing major regulations affecting your device can be
`found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
`publish further announcements concerning your device in the Federal Register.
`
`Please be advised that FDA's issuance of a substantial equivalence determination does not mean
`that FDA has made a determination that your device complies with other requirements of the Act
`or any Federal statutes and regulations administered by other Federal agencies. You must comply
`with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
`Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting (reporting of
`
`LUMENIS EX1021
`Page 19
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`

`

`Page 2
`
`- David Chmel
`
`medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
`as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
`electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
`1050.
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and
`Part 809), please contact the Division of Industry and Consumer Education at its toll-free number
`(800) 638-2041 or (301) 796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
`the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
`807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
`CFR Part 803), please go to
`http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
`of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`You may obtain other general information on your responsibilities under the Act from the
`Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
`796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
`
`Sincerely,
`
`Michael J. Hoffmann -S
`
`for
`
`Carlos L. Peña, PhD, MS
`Director
`Division of Neurological
`and Physical Medicine Devices
`Office of Device Evaluation
`Center for Devices and Radiological Health
`
`Enclosure
`
`LUMENIS EX1021
`Page 20
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`

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`
`LUMENIS EX1021
`Page 21
`
`

`

`
`
`510(k) Summary
`
`
`
`General Information
`
`Sponsor:
`
`
`
`
`
`Applicant:
`
`
`
`
`
`Contact Person:
`
`
`
`Summary Preparation
`Date:
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`David Chmel
`BTL Industries, Inc.
`chmel@btlnet.com
`
`February 16, 2017
`
`Device Name
`
`
`
`Trade/Proprietary Name:
`
`AM-100
`
`Primary Classification Name:
`
`Stimulator, Muscle, Powered
`
`Classification Regulation:
`
`21 CFR 890.5850, Class II
`
`Classification Product Code:
`
`NGX
`
`
`
`Legally Marketed Predicate Devices
`
`The AM-100 is a state-of-the-art magnetic device with accessories, and is substantially
`equivalent to the current product that is already cleared for distribution in the USA under the
`following 510(k) Premarket Notification number:
`
`(cid:120) Torc Body (K131291)
`
`
`
`
`510(k) Summary - Page 1 of 6
`
`LUMENIS EX1021
`Page 22
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`

`

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`
`
`The HPM-6000 device was used as a reference device to support the determination of
`substantial equivalence. The HPM-6000 is cleared (K160992) as a PMS device because it
`elicits a muscle contraction.
`
`Product Description
`
`The AM-100 is a non-invasive therapeutic device. The device produces electromagnetic field
`that interacts with the tissues of the human body. By muscle stimulation, the