Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053324
    Device Name
    CHROMOLITE SYSTEM
    Manufacturer
    CHROMOGENEX PLC
    Date Cleared
    2006-01-05

    (35 days)

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

    CHROMOGENEX PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows: - The treatment of moderate inflammatory acne vulgaris . - The treatment of benign pigmented epidermal lesions . including dyschromia, hyper-pigmentation, melasma, ephelides (freckles) - The treatment of cutaneous lesions including warts, scars, . and striae. - The treatment of benign cutaneous vascular lesions, . including port wine stains, hemangiomas, facial, truncal and leq telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. - The removal of unwanted hair and to effect stable long-. term or permanent hair reduction.
    Device Description
    The Chromolite™ is a Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Chromolite™ emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of 0.5Hz.
    Ask a Question

    Page 1 of 1