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

    CYNOSURE CELLULAZE LASER

    K Number: K102541 · Decision Jan 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    91
    Review Days
    510

    Basic Information

    Device Name
    CYNOSURE CELLULAZE LASER
    K Number
    K102541
    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
    CYNOSURE, INC.
    Date Received
    September 3, 2010
    Decision Date
    January 26, 2012
    Product Code
    OYW
    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
    OYW Laser, Cellulite Appearance

    Similar 510(k) Clearances

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

    CELLULAZE LASER

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

    Other Clearances by CYNOSURE, INC.

    K Number Device Name
    K160470 SculpSure
    K150724 SculpSure
    K150230 SculpSure
    K143105 Picosure Workstation
    K141511 SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
    K142376 Palomar Icon Aesthetic System
    K140719 PICOSURE WORKSTATION
    K141425 ELITE + LASER SYSTEM
    K133364 PICOSURE WORKSTATION
    K133254 REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
    Search all 91 clearances from CYNOSURE, INC. →