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

    RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012

    K Number: K033183 · Decision Apr 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    6
    Review Days
    197

    Basic Information

    Device Name
    RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
    K Number
    K033183
    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
    CURELIGHT LTD
    Date Received
    October 1, 2003
    Decision Date
    April 15, 2004
    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

    Similar 510(k) Clearances

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

    AviClear Laser System

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

    Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

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

    Pastelle

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

    SurgiLight 1470 Diode Laser System (Model:Halo)

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

    AuroLase® System

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

    Diode laser device (RF3120-BI)

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

    Other Clearances by CURELIGHT LTD

    K Number Device Name
    K041994 MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
    K041569 CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
    K032383 MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
    K030338 ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
    K013623 CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420