Cleared Special

K991527 - CHROMOPHARE D500, D530, D650

K991527 is an FDA 510(k) clearance for CHROMOPHARE D500, 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 24-day FDA review.

K991527 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
24d
Days
Class 2
Risk

K991527 is an FDA 510(k) clearance for the CHROMOPHARE D500, D530, D650. 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 May 27, 1999 after a review of 24 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Berchtold Holding GmbH devices

FDA 510(k) Submission Details - K991527

510(k) Number K991527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date May 27, 1999
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 26
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K991527.
STELLAR
K002463 · Skytron, Div. the Kmw Group, Inc. · Nov 2000
MILLENNIUM GOLD
K992090 · Skytron, Div. the Kmw Group, Inc. · Sep 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · Berchtold Holding GmbH · Jul 1999
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · Berchtold Holding GmbH · Feb 1998
CHROMOPHARE
K965130 · Berchtold Holding GmbH · Jul 1997