BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COOLTOUCH

    K Number: K103338 · Decision Nov 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    29
    Review Days
    351

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    Basic Information

    Device Name
    COOLTOUCH
    K Number
    K103338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New Star Lasers, Inc.
    Date Received
    November 15, 2010
    Decision Date
    November 1, 2011
    Product Code
    PDZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

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    Other Clearances by New Star Lasers, Inc.

    K Number Device Name
    K142286 NS3000 Holmium Laser System
    K132607 NS 2500 HOLMIUM LASER SYSTEM
    K101783 COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
    K092964 COOLTOUCH VARIA ND:YAG LASER SYSTEM
    K090410 COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
    K081628 MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
    K080163 COOLTOUCH MODELS LC215 AND COOLLIPO
    K072751 COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
    K072424 COOLTOUCH, MODEL LC215,COOLLIPO
    K061618 COOLTOUCH, MODEL CTEV
    Search all 29 clearances from New Star Lasers, Inc. →