Cleared Traditional

K990656 - CHROMOPHARE D 530 LDR SURGICAL LIGHT

K990656 is an FDA 510(k) clearance for CHROMOPHARE D 530 LDR SURGICAL LIGHT, 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 141-day FDA review.

K990656 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
141d
Days
Class 2
Risk

K990656 is an FDA 510(k) clearance for the CHROMOPHARE D 530 LDR SURGICAL LIGHT. 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 20, 1999 after a review of 141 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. 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 - K990656

510(k) Number K990656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date July 20, 1999
Days to Decision 141 days
Submission Type Traditional
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
26d slower than avg
Panel avg: 115d · This submission: 141d
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 K990656.
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002
STELLAR
K002463 · Skytron, Div. the Kmw Group, Inc. · Nov 2000
MILLENNIUM GOLD
K992090 · Skytron, Div. the Kmw Group, Inc. · Sep 1999
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