Cleared Traditional

K864380 - LUTEX HEADLIGHT SYSTEMS

K864380 is an FDA 510(k) clearance for LUTEX HEADLIGHT SYSTEMS, manufactured by Luxtec Corp.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K864380 · Luxtec Corp. · General & Plastic Surgery device
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Nov 1986
Decision
14d
Days
Class 2
Risk

K864380 is an FDA 510(k) clearance for the LUTEX HEADLIGHT SYSTEMS. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Luxtec Corp. (Sturbridge, US). The FDA issued a Cleared decision on November 19, 1986 after a review of 14 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 Luxtec Corp. devices

FDA 510(k) Submission Details - K864380

510(k) Number K864380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date November 19, 1986
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 16
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K864380.
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875006 · Advanced Surgical Products, Inc. · Mar 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007 · Advanced Surgical Products, Inc. · Mar 1988
MVS FIBEROPTIC LIGHTPIPE
K870942 · Advanced Surgical Products, Inc. · Apr 1987
HEADLIGHTS W/ FILTER-OPTICO CABLES
K761142 · Pilling Co. · Jan 1977