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510(k) Data Aggregation

    K Number
    K253342

    Validate with FDA (Live)

    Device Name
    PICO-K
    Manufacturer
    Date Cleared
    2025-12-24

    (85 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 PICO-K is intended for use in the following indications at the specified wavelength:

    1064 nm wavelength

    • Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
    • Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
    • Treatment of acne scars in Fitzpatrick Skin Types II-V
    • Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV

    532 nm wavelength

    • Tattoo removal in Skin Types I - III
    • Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
    Device Description

    The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Three different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, and MLA handpiece. Each handpiece integrates and aiming beam that shows the treatment area.

    The Nd:YAG laser surgical system employs a solid-state laser with a medium of Nd:YAG at 1064 nm and KTP at 532 nm. The energy from the 1064 nm wavelengths emitted by the laser is directed at the cells or tissues of the skin, raising the temperature of the targeted tissue according to the Selective Photothermolysis Theory. This selective heating of the tissue results in the cutting, destruction, or removal of the tissue through the heat energy produced by the laser.

    PICO-K employs a patented resonator design with optics aligned under controlled thermal lensing conditions. At high repetition rates (8–10 Hz), thermal lensing of the Nd:YAG rod can degrade beam quality in conventional systems. In PICO-K, the lamp frequency is fixed at 8–10 Hz, optical alignment is optimized under these conditions, and laser emission is generated only at divisor frequencies (1, 2, 3, 4, 5, 8, 9, 10 Hz).

    AI/ML Overview

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