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510(k) Data Aggregation

    K Number
    K253828

    Validate with FDA (Live)

    Date Cleared
    2026-02-27

    (88 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Alexandrite and Nd:YAG laser Therapy System is indicated for the following at the specified wavelength:

    755nm

    • Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin.
    • Treatment of benign pigmented lesions.
    • Treatment of wrinkles.
    • The photocoagulation of dermatological benign vascular lesions (such as portwine stains, hemangiomas, telangiectasias)

    1064nm

    • Removal of unwanted hair, for stable long term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis.
    • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
    • Treatment of wrinkles.
    • Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
    Device Description

    The Medical Alexandrite and Nd:YAG laser Therapy System is a Nd: YAG and Alexandrite laser operating at wavelengths of 1064 nm and 755 nm. The Medical Alexandrite and Nd:YAG laser Therapy System consists of the main unit, optical fiber, handpiece, treatment tip, footswitch, and handpiece holder and other accessories. The laser output is delivered to the skin through the optical fiber terminated by the handpiece. The Medical Alexandrite and Nd:YAG laser Therapy System is used for a variety of medical purpose. For treatment, the user can select the appropriate wavelength and the related output energy value by pressing UP and/or DOWN button from the LCD display/Touch Pad located on the front of the main unit.

    AI/ML Overview

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