Cleared Traditional

K965130 - CHROMOPHARE

K965130 is an FDA 510(k) clearance for CHROMOPHARE, manufactured by Berchtold Holding GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K965130 · Berchtold Holding GmbH · General & Plastic Surgery device
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Jul 1997
Decision
203d
Days
Class 2
Risk

K965130 is an FDA 510(k) clearance for the CHROMOPHARE. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Berchtold Holding GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on July 14, 1997 after a review of 203 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.

View all Berchtold Holding GmbH devices

FDA 510(k) Submission Details - K965130

510(k) Number K965130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date July 14, 1997
Days to Decision 203 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
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
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 - FSY Light, Surgical, Ceiling Mounted

All 26
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K965130.
CHROMOPHARE D500, D530, D650
K991527 · Berchtold Holding GmbH · May 1999
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · Berchtold Holding GmbH · Feb 1998
CHROMOPHARE
K944855 · Berchtold Holding GmbH · Oct 1994
AMSCO SQ240 SURGICAL LIGHT
K943288 · American Sterilizer Co. · Oct 1994
SKYTRON INFINITY SERIES SURGICAL LIGHTS
K915285 · Skytron, Div. the Kmw Group, Inc. · Feb 1992