Cleared Traditional

K935102 - SATURN LIGHT

K935102 is an FDA 510(k) clearance for SATURN LIGHT, manufactured by Burton Medical Products Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K935102 · Burton Medical Products Corp. · General & Plastic Surgery device
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Jun 1994
Decision
248d
Days
Class 2
Risk

K935102 is an FDA 510(k) clearance for the SATURN LIGHT. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 248 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K935102

510(k) Number K935102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1993
Decision Date June 27, 1994
Days to Decision 248 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
133d slower than avg
Panel avg: 115d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
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 - FTA Light, Surgical, Accessories

All 25
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K935102.
DISPOSABLE LIGHT HANDLE AND ADAPTOR
K020304 · Aspen Surgical Products, Inc. · Feb 2002
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
K993089 · Deroyal Cardiovascular, Inc. · Oct 1999
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
K954940 · Mdt Biologic Co. · Jan 1996
PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER
K915068 · American Medical Mfg., Inc. · Feb 1992
MICROTEK'S SURGICAL LAMP HANDLE & COVER
K901154 · Microbio-Medics, Inc. · Mar 1990
WELCON LIGHT HANDLE
K894397 · Welcon, Inc. · Aug 1989
K935102 · SATURN LIGHT
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