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510(k) Data Aggregation

    K Number
    K041323
    Device Name
    PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2004-11-17

    (183 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K984042,K041793,K050854
    Predicate For
    K052336
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CoolTouch PRIMA Pulsed Light Therapy System is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.

    Device Description

    The CoolTouch PRIMA Pulsed Light Therapy System is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console unit. which houses the power supply, cooling system, cryogen source, and microcontroller, the handpiece, which contains the light source, and the footswitch.

    AI/ML Overview

    The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    Instead, it's a 510(k) summary for the CoolTouch PRIMA Pulsed Light Therapy System, focusing on its substantial equivalence to predicate devices for various dermatological treatments. The document explicitly states "Nonclinical Performance Data: None. Clinical Performance Data: None."

    Therefore, I cannot provide the requested information based on the given text.

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