BEUDAMED
    Product Code: FST FDA class 2 21 CFR 878.4580

    Light, Surgical, Fiberoptic

    General, Plastic Surgery

    A fiberoptic surgical light is a lighting system that uses fiber optic cables to transmit light from a remote source to the surgical field or instrument, providing bright, cool illumination. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FST, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    45
    FEI Numbers
    71
    Registration Numbers
    71
    Unique Applicants
    35
    Years Active
    43

    Basic Information

    Product Code
    FST
    Device Class
    FDA class 2
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 45 510(k) clearances via K numbers.

    K Number Device Name
    K200874 TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
    K141330 ENDO-CORD
    K122637 LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
    K113697 EIGR SURGICAL ILLUMINATION SYSTEM
    K113330 CABLECAP
    K102266 ISOLED AC-POWERED LED HEADLIGHT SYSTEM
    K101496 CABLECAP MODEL: WLF, STZ, ACM
    K100388 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
    K100395 HARMONY VLED SURGICAL LIGHTNING SYSTEM
    K093386 CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
    K090070 INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
    K083710 RETRACTOR LITE
    K082992 AXXION LIGHT GUIDE
    K080962 LITE WAND II
    K080367 ZIMMER MIS LIGHT
    K071218 PROXENON 350, MODEL 902XX
    K061690 SURGICAL HEADLIGHT
    K053227 LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
    K051786 MELIDE FIBEROPTIC LIGHT
    K042034 NUVASIVE MAXCESS LIGHT GUIDE
    K003577 STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
    K000728 MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
    K991572 ISOLUX SURGICAL HEADLIGHT
    K972225 UFR FIBEROPTIC CABLE
    K955510 X6000D SILENT SUN LIGHT SOURCE
    K936048 LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
    K931546 END-IRRIGATING ENDOILLUMINATOR
    K922820 WOODBINE XT350, XENON ARC LIGHT SOURCE
    K922544 MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
    K921646 NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
    K915274 METAL HALIDE LIGHT SOURCE MODEL LM 250
    K912252 INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
    K903800 FIBER OPTIC LIGHT CABLE
    K901491 CUDA SURGICAL LIGHT
    K901035 FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
    K893828 ML-800 AUTOELECTRONIC LIGHT SOURCE
    K893491 MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
    K875007 PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
    K875006 PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
    K875005 PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
    K875004 PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
    K875195 OPHTHALMIC LIGHT PIPE PICK
    K870942 MVS FIBEROPTIC LIGHTPIPE
    K864380 LUTEX HEADLIGHT SYSTEMS
    K761142 HEADLIGHTS W/ FILTER-OPTICO CABLES

    FEI Numbers

    This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.