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510(k) Data Aggregation

    K Number
    K183708
    Device Name
    Poly Clear
    Manufacturer
    Medtek Skincare, LLC
    Date Cleared
    2019-09-17

    (260 days)

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

    Medtek Skincare, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly Clear combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
    Device Description
    The Poly Clear is a portable device that has three separate detachable treatment heads, each containing a total of 1,820 LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment heads) for the device. 6 pairs of protective eyewear are included with the device.
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    K Number
    K180875
    Device Name
    POLY REJUV
    Manufacturer
    Medtek Skincare, LLC
    Date Cleared
    2018-09-14

    (164 days)

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

    Medtek Skincare, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    The Poly Rejuv is a portable device that has a detachable treatment head, containing a total of 1,820 red LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment head) for the device. 12 pairs of protective eyewear are included with the device. The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use. The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.
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