Cleared Special

K024132 - CHROMOPHARE X 65

K024132 is an FDA 510(k) clearance for CHROMOPHARE X 65, manufactured by Berchtold Holding GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Special 510(k) pathway after a 95-day FDA review.

K024132 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
95d
Days
Class 2
Risk

K024132 is an FDA 510(k) clearance for the CHROMOPHARE X 65. 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 March 21, 2003 after a review of 95 days - within the typical 510(k) review window.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K024132

510(k) Number K024132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date March 21, 2003
Days to Decision 95 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

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 69
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K024132.
STRYKER VISUM SURGICAL LIGHTING SYSTEM
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K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693 · Trumpf Medical Systems, Inc. · Jun 2001
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
K010716 · Valmed Corp. · May 2001
K024132 · CHROMOPHARE X 65
Download PDF FDA Summary Berchtold Holding GmbH