Cleared Traditional

K915274 - METAL HALIDE LIGHT SOURCE MODEL LM 250

K915274 is an FDA 510(k) clearance for METAL HALIDE LIGHT SOURCE MODEL LM 250, manufactured by Pentax Precision Instrument Corp.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K915274 · Pentax Precision Instrument Corp. · General & Plastic Surgery device
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Jan 1992
Decision
59d
Days
Class 2
Risk

K915274 is an FDA 510(k) clearance for the METAL HALIDE LIGHT SOURCE MODEL LM 250. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 59 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 Pentax Precision Instrument Corp. devices

FDA 510(k) Submission Details - K915274

510(k) Number K915274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date January 23, 1992
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 28
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K915274.
UFR FIBEROPTIC CABLE
K972225 · Universal Fiberoptic Repair, Inc. · Mar 1998
X6000D SILENT SUN LIGHT SOURCE
K955510 · Products For Medicine · Jan 1996
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
CUDA SURGICAL LIGHT
K901491 · Cuda Products Co. · Jun 1990
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
K901035 · Cuda Products Co. · Apr 1990
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · Cuda Products Co. · Jun 1989