Cleared Traditional

CHROMOPHARE D 530 LDR SURGICAL LIGHT (K990656) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990656 · Berchtold Holding GmbH · General & Plastic Surgery device
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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.

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Submission Details

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
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.

Device Classification

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.