Cleared Traditional

K090378 - CHROMOPHARE E 668

K090378 is an FDA 510(k) clearance for CHROMOPHARE E 668, manufactured by Berchtold GmbH & Co. KG. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K090378 · Berchtold GmbH & Co. KG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
6d
Days
Class 2
Risk

K090378 is an FDA 510(k) clearance for the CHROMOPHARE E 668. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Berchtold GmbH & Co. KG (Charleston, US). The FDA issued a Cleared decision on February 23, 2009 after a review of 6 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K090378

510(k) Number K090378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2009
Decision Date February 23, 2009
Days to Decision 6 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 115d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K090378.
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MACH LED SC
K093009 · Dr. Mach GmbH & Co. KG · Apr 2010
MACH LED MC
K093010 · Dr. Mach GmbH & Co. KG · Apr 2010
NUVO VERDE LED LIGHTING SYSTEM
K083323 · Nuvo, Inc. · Jan 2009
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K083066 · Berchtold Holding GmbH · Oct 2008
CHROMOPHARE E-SERIES
K080857 · Berchtold Holding GmbH · Apr 2008

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K090378 · CHROMOPHARE E 668
Download PDF FDA Summary Berchtold GmbH & Co. …