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

    DERMABLATE ER: YAG LASER SYSTEM

    K Number: K980361 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    6
    Review Days
    82

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    Basic Information

    Device Name
    DERMABLATE ER: YAG LASER SYSTEM
    K Number
    K980361
    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
    Aesculap-Meditec North America
    Date Received
    January 29, 1998
    Decision Date
    April 21, 1998
    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

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    Other Clearances by Aesculap-Meditec North America

    K Number Device Name
    K994116 LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
    K992707 MCL 29 DERMABLATE ER:YAG LASER SYSTEM
    K991285 LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
    K981196 MEDITEC LINK
    K974467 AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08