Cleared Traditional

K860088 - PL EXAM LIGHT

K860088 is an FDA 510(k) clearance for PL EXAM LIGHT, manufactured by Burton Medical Products Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K860088 · Burton Medical Products Corp. · General & Plastic Surgery device
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Jan 1986
Decision
14d
Days
Class 2
Risk

K860088 is an FDA 510(k) clearance for the PL EXAM LIGHT. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 14 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 Burton Medical Products Corp. devices

FDA 510(k) Submission Details - K860088

510(k) Number K860088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1986
Decision Date January 24, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTD Device Classification - Class 2, Special Controls

Product Code FTD Lamp, Surgical
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 - FTD Lamp, Surgical

All 14
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K860088.
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994
MINOR SURGICAL LIGHT MODEL 180
K841360 · American Sterilizer Co. · Apr 1984
SURGICAL LIGHT
K823360 · Amsco Co. · Dec 1982
CASTLE & RITTER MINOR SURG. & EXAM LT
K811728 · Sybron Corp. · Jul 1981