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510(k) Data Aggregation

    K Number
    K252345

    Validate with FDA (Live)

    Date Cleared
    2025-10-23

    (87 days)

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

    The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

    1064nm wavelength:

    • Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

    532nm wavelength:

    • Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
    Device Description

    The Picosecond Laser Device mainly consists of a main unit, a light guide arm, a standard handpiece, a foot switch, a power cord, and other auxiliary treatment accessories.

    The main unit includes power supply unit, control unit, laser system, water circulation cooling system.

    Accessories include goggles, eye mask, funnel assembly, drainage nozzle, fuse tubes, remote control interlock connector, and keys.

    The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).

    AI/ML Overview

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