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510(k) Data Aggregation

    K Number
    K252447
    Date Cleared
    2025-10-01

    (58 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

    Composition of therapeutic device: main unit, light guide arm, handpiece and foot switch. The main unit includes display screen, laser, power supply, water circulation cooling system and electronic control components. Accessories include goggles, eye mask, standard hand tools, power cord, fuse tube, funnel component, drain faucet, user manual, remote control interlock connector, drain spout and keys.

    The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions and removal of tattoos. 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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