Cleared Traditional

K071698 - AURORA LED SERIES SURGICAL LIGHTS

K071698 is an FDA 510(k) clearance for AURORA LED SERIES SURGICAL LIGHTS, manufactured by Skytron, Div. the Kmw Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K071698 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
15d
Days
Class 2
Risk

K071698 is an FDA 510(k) clearance for the AURORA LED SERIES SURGICAL LIGHTS. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on July 6, 2007 after a review of 15 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 Skytron, Div. the Kmw Group, Inc. devices

FDA 510(k) Submission Details - K071698

510(k) Number K071698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2007
Decision Date July 06, 2007
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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

Intertek Testing Services
DANIEL W LEHTONEN

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 52
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K071698.
CHROMOPHARE E 778 AND E 558
K083066 · Berchtold Holding GmbH · Oct 2008
CHROMOPHARE E-SERIES
K080857 · Berchtold Holding GmbH · Apr 2008
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
POWERLED SURGICAL LIGHT SYSTEM
K070442 · Maquet S.A. · Mar 2007
M3
K063333 · Mavig GmbH · Nov 2006
ILED
K061317 · Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · Jun 2006

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.