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    Attachment 2 510 (K) SUMMARY: 5 10 (K) Owner: 892 Steger Towne RD Suite # 44

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    x620
    The Sunetics Clinical Laser is a low-level laser device intended to treat hair loss and promote hair growth in males and females. It utilizes red laser light distributed from an open panel hood containing laser modules with a 650nm wavelength and less than 5mW output power. Performance testing confirmed it is as safe and effective as similar legally marketed predicate devices cleared through 510(k), including the MEP-90 Hair Growth Stimulation System and igrow 11 Hair Growth System. Specifically, testing showed it has the same laser wavelength, output power, output beam, energy type, laser field, treatment area and energy delivery. The FDA determined the Sunetics Clinical Laser to be substantially equivalent to the predicate devices.

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    Attachment 2 510 (K) SUMMARY: 5 10 (K) Owner: 892 Steger Towne RD Suite # 44

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    x620
    106 views5 pages
    The Sunetics Clinical Laser is a low-level laser device intended to treat hair loss and promote hair growth in males and females. It utilizes red laser light distributed from an open panel hood containing laser modules with a 650nm wavelength and less than 5mW output power. Performance testing confirmed it is as safe and effective as similar legally marketed predicate devices cleared through 510(k), including the MEP-90 Hair Growth Stimulation System and igrow 11 Hair Growth System. Specifically, testing showed it has the same laser wavelength, output power, output beam, energy type, laser field, treatment area and energy delivery. The FDA determined the Sunetics Clinical Laser to be substantially equivalent to the predicate devices.

    Original Description:

    k 132646

    Original Title

    k 132646

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    The Sunetics Clinical Laser is a low-level laser device intended to treat hair loss and promote hair growth in males and females. It utilizes red laser light distributed from an open panel hood containing laser modules with a 650nm wavelength and less than 5mW output power. Performance testing confirmed it is as safe and effective as similar legally marketed predicate devices cleared through 510(k), including the MEP-90 Hair Growth Stimulation System and igrow 11 Hair Growth System. Specifically, testing showed it has the same laser wavelength, output power, output beam, energy type, laser field, treatment area and energy delivery. The FDA determined the Sunetics Clinical Laser to be substantially equivalent to the predicate devices.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    106 views5 pages

    Attachment 2 510 (K) SUMMARY: 5 10 (K) Owner: 892 Steger Towne RD Suite # 44

    Uploaded by

    x620
    The Sunetics Clinical Laser is a low-level laser device intended to treat hair loss and promote hair growth in males and females. It utilizes red laser light distributed from an open panel hood containing laser modules with a 650nm wavelength and less than 5mW output power. Performance testing confirmed it is as safe and effective as similar legally marketed predicate devices cleared through 510(k), including the MEP-90 Hair Growth Stimulation System and igrow 11 Hair Growth System. Specifically, testing showed it has the same laser wavelength, output power, output beam, energy type, laser field, treatment area and energy delivery. The FDA determined the Sunetics Clinical Laser to be substantially equivalent to the predicate devices.

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    of 5

    K132646 Page 1 of 2

    DEC 202013
    ATTACHMENT 2
    510(k) SUMMARY
    510(k) Owner:

    Sunetics International Marketing Group LLC


    892 Steger Towne Rd Suite # 44
    Rockwall, TX 75032
    Contact:
    John Carullo
    214-683-0724
    Phone:

    Date Summary
    Prepared:

    August 9, 2013

    Device:

    Trade Name:

    Sunetics Clinical Laser "G" or "W2326"

    Common/Classification Name:

    Light Therapy Hair System


    Product Code OAP; NHN
    21 C.IKR. 890.5500 (Infrared lamp)

    Classification:

    Class 11

    Predicate
    Devices:

    MEP-90 Hair Growth Stimulation System


    igrow 11 Hair Growth System

    Device
    Description:

    August 9, 2013

    Midwest RF LLC

    K09 1496

    Apira Science Inc - K122248

    Theradome LH80 PRO Laser Helmet

    Theradome Inc - K 122950

    Theradome Laser Helmet LH80 PRO

    Theradome Inc

    KI 113097

    The Sunetics Clinical Laser (model "0" & model "W2326") is a stationary.
    non-invasive, low-level laser device intended to treat Androgenetic Alopecia
    (Hair Loss) and to promote hair growth in both Males and Females. The
    Sunetics Clinical Laser device provides distributed red laser light dispersing
    from an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength,
    <5 mW output power, producing a continuous wave "CW" output beam. The
    "Open Panel" Hood is designed to maximize the delivery of the coherent laser
    light to effectively cover the entire scalp of the user during treatment.

    K132646 Page 2 of 2
    Sunetits International Marketing Group LLC

    510(k) Submission
    Sunetics Clinical Laser

    Intended Use:

    The Sunetics Clinical Laser (model '0" & model "W2326") is indicated to
    treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males
    who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Skin
    Types I to IV and also in Females who have Ludwig (Savin) 1-4.11I-1, 11-2, or
    frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.

    Technological
    Characteristics:

    The Sunetics Clinical Laser (model "0" & model "W2326") is a stationary
    device that produces red laser energy dispersed from an "Open Panel" Hood
    array as it rests slightly above a patient's head and creates a laser field that
    covers the patients entire scalp area. The device produces timed treatments of
    equally distributed laser energy to the full scalp area. The medically prescribed
    treatment received from the laser energy promotes hair growth in Males and
    Females and treats Androgenetic Alopecia (Hair Loss) by the therapeutic
    modality of bio-stimulation.

    Biocompatibility
    Data:

    Not applicable.

    Performance
    Data:

    The evaluation of the perfomnance data presented confirms that the Sunetics
    Clinical Laser (model "G" & model "W2326") has the same or similar laser
    wavelength, output power. output beam, energy type. laser field, treament area
    and energy delivery as the FDA Cleared predicate devices.
    Testing to IEC 60601 -1 and 60601-1-2 confirm the devices adherence to LVD
    electrical and EMC safectly requirements. Testing to IEC 60825-1 certifies the
    laser system to classifiaction 3R, which is the same as the predicate devices.
    Performance Testing is conducted to confirm compliance to design
    specifications; all functions were verified to operate as designed. The Sunetics
    Clinical Laser met all acceptance criteria in the performance testing.

    Conclusions:

    August 9, 2013

    The Sunetics Clinical Laser (model "G" & model "W2326") is as safe and
    effective as the FDA Cleared predicate devices and is thefore Substantial
    Equivalent to the FDA Cleared predicate devices with respect to intended use,
    technological characteristics and safety characteristics.

    DEATETOF HEALTH & HUMAN SERVICES

    Public Health Service

    Sunetics International Marketing Group LLC


    Mr. John Carullo
    Managing Member
    892 Steger Towne Road, Suite 44
    Rockwall, Texas 75032

    Food and Drug Administration


    10903 New Hampshire Avenue
    Document Control Centr - W066-0609
    Silver Spring, MD 20993-0002

    December 20,

    2013

    Re: K132646
    Trade/Device Name: Sunetics Clinical Laser "G" or "W2326"
    Regulation Number: 21 CFR 890.5500
    Regulation Name: Infrared lamp
    Regulatory Class: Class 11
    Product Code: OAP, NHN
    Dated: November 21, 2013
    Received: November 25, 2013
    Dear Mr. Carullo:
    We have reviewed your Section 5 10(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, maurket 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.
    lf your device is classified (see above) into either class HI(Special Controls) or class Ill (PMA),
    it may be subject to additional controls. Existing major regulations affecting your device can be
    found in the Code of Federal Regulations, Title 2 1, 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

    Page 2 - Mr. John Carullo


    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 80 1), please
    contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7 100 or at its Internet address
    http)://www.fda.2ov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
    the regulation entitled, "Misbranding by reference to premarket notification" (2 ICFR Part
    807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
    CFR Part 803), please go to
    httr)://www.fda.gov/Medica]Devices/Safetv/ReportaProblem/defau lt.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 Small Manufacturers, International and Consumer Assistance at its toll-free number
    (800) 638-2041 or (301) 796-7100 or at its Internet address
    http://Nvww.fda.gov[Medicalflevices/ResourcesforYou/industry/default.htm.
    Sincerely yours,

    Josh ua[~,C7,5- "'pper -S


    Binita S. Ashar, M.D. M.B.A. F.A.C.S.
    For Acting Director
    Division of Surgical Devices
    Office of Device Evaluation
    Center for Devices and
    Radiological Health
    Enclosure

    Indications For Use

    5 10(k) Number __KI32646


    (if known):
    Device Name:

    Sunetics Clinical Laser ...... models: "G" & "W2326"

    Indications for Use: The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia
    (Hair Loss) and to promote hair growth in Males who have Norwood
    Hamilton Classifications of Ila to V and Fitzpatrick Skin Types I to IV.
    The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia
    (Hair Loss) and to promote hair growth in Females who have Ludwig
    (Savin) l-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin
    Types I to IV.

    AND/OR
    Prescription Use _ X_
    0)
    (Part 21 CFR 801 Subpart

    Over-The-Counter Use
    (21 CFR 801 Subpart C)

    ____

    PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
    Concurrence of CDRH, Office of Device Evaluation (ODE)

    Neil ROgden -S
    2013.12.20 15:34:52 -05'00'
    (Division Sign-Off) for

    BSA

    Division of Surgical Devices


    510(k) Number

    K132646

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