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

    MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO

    K Number: K081628 · Decision Jun 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    29
    Review Days
    10

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
    K Number
    K081628
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New Star Lasers, Inc.
    Date Received
    June 10, 2008
    Decision Date
    June 20, 2008
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PICOSURE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LumiGlam Laser System (SHE-LSP601-3)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LASEmaR 1500

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LUNE PureHygiene

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Boston 2910 (Boston 2910)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by New Star Lasers, Inc.

    K Number Device Name
    K142286 NS3000 Holmium Laser System
    K132607 NS 2500 HOLMIUM LASER SYSTEM
    K103338 COOLTOUCH
    K101783 COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
    K092964 COOLTOUCH VARIA ND:YAG LASER SYSTEM
    K090410 COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
    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. →