Cleared Traditional

K080857 - CHROMOPHARE E-SERIES

K080857 is an FDA 510(k) clearance for CHROMOPHARE E-SERIES, 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 14-day FDA review.

K080857 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
14d
Days
Class 2
Risk

K080857 is an FDA 510(k) clearance for the CHROMOPHARE E-SERIES. 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 April 10, 2008 after a review of 14 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.

View all Berchtold Holding GmbH devices

FDA 510(k) Submission Details - K080857

510(k) Number K080857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2008
Decision Date April 10, 2008
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 26
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K080857.
CHROMOPHARE E 778 AND E 558
K083066 · Berchtold Holding GmbH · Oct 2008
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
AURORA LED SERIES SURGICAL LIGHTS
K071698 · Skytron, Div. the Kmw Group, Inc. · Jul 2007
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy · Aug 2003
CHROMOPHARE X 65
K024132 · Berchtold Holding GmbH · Mar 2003
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002

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.