BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    INTENSIF

    K Number: K130501 · Decision Mar 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    379

    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
    INTENSIF
    K Number
    K130501
    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
    Endymed Medical, Ltd.
    Date Received
    February 27, 2013
    Decision Date
    March 13, 2014
    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.

    VIVACE Electrosurgical System

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

    INTRAGen

    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

    Other Clearances by Endymed Medical, Ltd.

    K Number Device Name
    K242996 EndyMed PRO MAX
    K222369 PURE Laser
    K161715 EndyGel
    K161199 EndyMed Contour Handpiece
    DEN150005 Newa Skin Therapy System
    K120513 GLOW BY ENDYMED
    K101510 FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR