BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    SmoothCool HR System

    K Number: K223685 · Decision Jan 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    26

    Basic Information

    Device Name
    SmoothCool HR System
    K Number
    K223685
    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
    Jeisys Medical Inc
    Date Received
    December 9, 2022
    Decision Date
    January 4, 2023
    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 Jeisys Medical Inc

    K Number Device Name
    K213484 SmoothCool HR System