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510(k) Data Aggregation

    K Number
    K252319
    Date Cleared
    2025-10-20

    (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 Q-Switched Nd: YAG Laser machine is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:

    1064nm:

    • Tattoo Removal
      Dark ink: blue and black.
    • Treatment of Benign Pigmented Lesions
      Nevus of ota.

    532nm:

    • Tattoo Removal
      Light ink: red, Light ink: sky blue and green.
    • Treatment of Benign Vascular Lesions
      Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
    • Treatment of Benign Pigmented Lesions
      Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
    Device Description

    The Q-Switched Nd: YAG Laser machine is a laser system which delivers light at a wavelength 1064nm or 532nm. The Q-Switched Nd: YAG Laser machine is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology. The device comprises a main unit, light guide arm and footswitch.

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