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

    VIVACE Electrosurgical System

    K Number: K150409 · Decision Jan 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    331

    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
    VIVACE Electrosurgical System
    K Number
    K150409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sung Hwan E&B Co.,Ltd
    Date Received
    February 18, 2015
    Decision Date
    January 15, 2016
    Product Code
    OUH
    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
    OUH Skin Resurfacing Rf Applicator

    Similar 510(k) Clearances

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

    INTRAGen

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

    INTENSIF

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

    GLOW BY ENDYMED

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

    FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR

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