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510(k) Data Aggregation

    K Number
    K202848
    Device Name
    S2 Pigment Removal System
    Date Cleared
    2021-12-14

    (445 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lightsense Technologies Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    S2 Pigment Removal System is intended for use in removal of tattoo ink. The S2 Pigment Removal System is indicated for the removal of tattoo ink according to the following wavelengths: 800 nm: The LightSense S2 800 nm Ti:Sapphire laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-III. 532 nm: The LightSense S2 532 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I - III. 1064 nm: The LightSense S2 1064 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-VI.
    Device Description
    The S2 Pigment Removal Laser System (S2) uses high intensity laser pulses to remove tattoo ink from skin. The S2 includes the two treatment lasers, an aiming beam, a small galvanometric scanner, an articulating arm, a hand-piece with an adjustable spacer, and a foot pedal. The S2 uses two lasers to deliver three working wavelengths: (1) 800nm, ultra-short pulsed Ti:Sapphire laser, and (2) 1064 and 532nm Nd:YAG short pulse laser. The combined lasers are designed to remove tattoos.
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