Cleared Traditional

K991572 - ISOLUX SURGICAL HEADLIGHT

K991572 is an FDA 510(k) clearance for ISOLUX SURGICAL HEADLIGHT, manufactured by Isolux America. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K991572 · Isolux America · General & Plastic Surgery device
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Jul 1999
Decision
64d
Days
Class 2
Risk

K991572 is an FDA 510(k) clearance for the ISOLUX SURGICAL HEADLIGHT. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Isolux America (Naples, US). The FDA issued a Cleared decision on July 8, 1999 after a review of 64 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 Isolux America devices

FDA 510(k) Submission Details - K991572

510(k) Number K991572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1999
Decision Date July 08, 1999
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
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 21
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K991572.
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