Cleared Traditional

K080962 - LITE WAND II

K080962 is an FDA 510(k) clearance for LITE WAND II, manufactured by Thompson Surgical Instruments, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K080962 · Thompson Surgical Instruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
82d
Days
Class 2
Risk

K080962 is an FDA 510(k) clearance for the LITE WAND II. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Thompson Surgical Instruments, Inc. (Traverse City, US). The FDA issued a Cleared decision on June 25, 2008 after a review of 82 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 Thompson Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K080962

510(k) Number K080962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2008
Decision Date June 25, 2008
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
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
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