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

    METAL HALIDE LIGHT SOURCE MODEL LM 250

    K Number: K915274 · Decision Jan 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    67
    Review Days
    59

    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
    METAL HALIDE LIGHT SOURCE MODEL LM 250
    K Number
    K915274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    November 25, 1991
    Decision Date
    January 23, 1992
    Product Code
    FST
    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
    FST Light, Surgical, Fiberoptic

    Similar 510(k) Clearances

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

    TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End

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

    ENDO-CORD

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

    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

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

    EIGR SURGICAL ILLUMINATION SYSTEM

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

    CABLECAP

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

    ISOLED AC-POWERED LED HEADLIGHT SYSTEM

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

    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K041395 EG-3630UR
    K041397 EG-3830UT
    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023376 EB-1830T3, VIDEO BRONCHOSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    Search all 67 clearances from Pentax Precision Instrument Corp. →