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

    CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160

    K Number: K022610 · Decision Nov 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    10
    Review Days
    91

    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
    CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
    K Number
    K022610
    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
    Clarus Medical, LLC
    Date Received
    August 6, 2002
    Decision Date
    November 5, 2002
    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.

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

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

    PICOSURE WORKSTATION

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

    LumiGlam Laser System (SHE-LSP601-3)

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

    LASEmaR 1500

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

    LUNE PureHygiene

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

    Boston 2910 (Boston 2910)

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

    Other Clearances by Clarus Medical, LLC

    K Number Device Name
    K252790 Digital ClarusScope System and Digital NeuroPEN System
    K240535 Digital ClarusScope System; Digital NeuroPEN System
    K223615 Digital ClarusScope System, Digital NeuroPEN System
    K200925 Clarus Peel-Away Introducer Sheath
    K082038 CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
    K040919 NUCLEOTOME PROBE SET, MODEL 21200
    K040424 LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
    K021848 CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160
    K011454 SPINE SCOPE, MODEL 2180