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510(k) Data Aggregation

    K Number
    K061720
    Device Name
    COSMELIGHT
    Date Cleared
    2007-01-31

    (226 days)

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

    PENNTACK ENTERPRISES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cosmelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, varlous benign pigmente lestons and hair removal as follow: 1. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the reatment of: inflammatory acne. 2. Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of: benign pigmented (epidermal and coetaneous) lesions including warts, cars and striae. For the treatment of benign (cutaneous) vascular lessons including ort wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations. 3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of: unwanted hair (i.e., hair removal).
    Device Description
    The Cosmelight Intense Pulsed Light System is comprised of the following main components: • A control console unit. • A control and color display panel. • Two removable handpieces with an integrated trigger switch and a Cooling System (a cooling device integrated into the handpieces. Quick Cool Handle ( QCH ) • Power supply.
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