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510(k) Data Aggregation

    K Number
    K042630
    Device Name
    REVLIGHT SKIN CARE SYSTEM
    Manufacturer
    SKINCARE TECHNOLOGY INC.
    Date Cleared
    2005-06-27

    (273 days)

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

    SKINCARE TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RevLight is intended for use to provide LED light to the body, and with the large pulsators, facial massage. Depending on the wavelength(s) of light delivered by the detachable Pulsators that are connected to the base unit, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
    Device Description
    RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies and the control unit. Attachable to the base unit are three sets of Pulsators that deliver the light to the skin as they are moved over the skin surface. The output of the Pulsators ranges from 420-940nm.
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