Cleared Traditional

K955510 - X6000D SILENT SUN LIGHT SOURCE

K955510 is an FDA 510(k) clearance for X6000D SILENT SUN LIGHT SOURCE, manufactured by Products For Medicine. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K955510 · Products For Medicine · General & Plastic Surgery device
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Jan 1996
Decision
58d
Days
Class 2
Risk

K955510 is an FDA 510(k) clearance for the X6000D SILENT SUN LIGHT SOURCE. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Products For Medicine (Irvine, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 58 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 Products For Medicine devices

FDA 510(k) Submission Details - K955510

510(k) Number K955510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date January 31, 1996
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K955510.
PROXENON 350, MODEL 902XX
K071218 · Welch Allyn, Inc. · Jun 2007
NUVASIVE MAXCESS LIGHT GUIDE
K042034 · Nuvasive, Inc. · Oct 2004
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · STERIS Corporation · Jan 2001
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · Advanced Surgical Products, Inc. · Mar 1988