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510(k) Data Aggregation

    K Number
    K152199
    Device Name
    RejuvatoneMD
    Manufacturer
    TROPHY SKIN, INC.
    Date Cleared
    2016-03-23

    (230 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY SKIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
    Device Description
    The RejuvatoneMD device is a non-invasive at-home facial stimulation device intended for cosmetic use. The device works by delivering low-level electrical microcurrent impulses through dual contact spheres to strategic locations on the face and allows users to adjust the output level for personalized comfort.
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    K Number
    K152019
    Device Name
    HairMD
    Manufacturer
    TROPHY SKIN, INC.
    Date Cleared
    2015-11-16

    (118 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY SKIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.
    Device Description
    The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by line voltage, operating at 110/220 volts.
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    K Number
    K133896
    Device Name
    REJUVALITE MD
    Manufacturer
    TROPHY SKIN, INC.
    Date Cleared
    2014-11-13

    (328 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY SKIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rejuvalite MD is an Over the Counter device that is intended for the treatment of full face wrinkles.
    Device Description
    The Rejuvalite MD, is a tabletop device that contains 120 LEDs split evenly into 4 different wavelengths. The total power density for combined wavelengths is approximately 62 mW/cm2 at a distance of 4" from the illuminating surface of the device. The labeling requires Users to maintain the distance between the illuminating surface and the treatment site at 4"during the treatment. There is a 4" distance limiting arm attached to the device to help users on determining and maintaining the 4" distance between the device's illuminating surface and the treatment site. The Rejuvalite MD system components include the tabletop unit consisting of the base, arm, and swivel head containing the LED module , 4" distance limiting arm, timer, internal UL approved power adapter, and goggles. The device incorporates a power adapter mounted inside of the lamp base that converts the AC to DC voltage. The power switch is operated to turn the device on or off. The unit is designed to be placed on a table for easy exposure to the face to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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