Cleared Traditional

K102266 - ISOLED AC-POWERED LED HEADLIGHT SYSTEM

K102266 is an FDA 510(k) clearance for ISOLED AC-POWERED LED HEADLIGHT SYSTEM, manufactured by Isolux, LLC. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K102266 · Isolux, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
45d
Days
Class 2
Risk

K102266 is an FDA 510(k) clearance for the ISOLED AC-POWERED LED HEADLIGHT SYSTEM. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Isolux, LLC (Naples, US). The FDA issued a Cleared decision on September 24, 2010 after a review of 45 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.

FDA 510(k) Submission Details - K102266

510(k) Number K102266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date September 24, 2010
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FST Light, Surgical, Fiberoptic

All 38
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K102266.
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K113697 · Invuity, Inc. · Feb 2012
CABLECAP
K113330 · Sensormed · Jan 2012
CABLECAP MODEL: WLF, STZ, ACM
K101496 · Sensormed · Sep 2010
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
K100388 · Medical Illumination International, Inc. · Jun 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K100395 · STERIS Corporation · Mar 2010

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.