Cleared Traditional

K903800 - FIBER OPTIC LIGHT CABLE

K903800 is an FDA 510(k) clearance for FIBER OPTIC LIGHT CABLE, manufactured by Orlux Engineering and Instrumentation. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K903800 · Orlux Engineering and Instrumentation · General & Plastic Surgery device
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Aug 1990
Decision
9d
Days
Class 2
Risk

K903800 is an FDA 510(k) clearance for the FIBER OPTIC LIGHT CABLE. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Orlux Engineering and Instrumentation (Brampton, Ontario, CA). The FDA issued a Cleared decision on August 29, 1990 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orlux Engineering and Instrumentation devices

FDA 510(k) Submission Details - K903800

510(k) Number K903800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date August 29, 1990
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FST Device Classification - Class 2, Special Controls

Product Code FST Light, Surgical, Fiberoptic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FST Light, Surgical, Fiberoptic

All 36
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K903800.
X6000D SILENT SUN LIGHT SOURCE
K955510 · Products For Medicine · Jan 1996
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
CUDA SURGICAL LIGHT
K901491 · Cuda Products Co. · Jun 1990
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
K901035 · Cuda Products Co. · Apr 1990
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · Cuda Products Co. · Jun 1989