Cleared Special

K100395 - HARMONY VLED SURGICAL LIGHTNING SYSTEM

K100395 is an FDA 510(k) clearance for HARMONY VLED SURGICAL LIGHTNING SYSTEM, manufactured by STERIS Corporation. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Special 510(k) pathway after a 29-day FDA review.

K100395 · STERIS Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
29d
Days
Class 2
Risk

K100395 is an FDA 510(k) clearance for the HARMONY VLED SURGICAL LIGHTNING SYSTEM. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 17, 2010 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100395

510(k) Number K100395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date March 17, 2010
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 44
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K100395.
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K100395 · HARMONY VLED SURGICAL LIGHTNING SYSTEM
Download PDF FDA Summary STERIS Corporation