Cleared Traditional

K060802 - VISUM LED SURGICAL LIGHTING SYSTEM

K060802 is an FDA 510(k) clearance for VISUM LED SURGICAL LIGHTING SYSTEM, manufactured by Stryker Communications Corp.. 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.

K060802 · Stryker Communications Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
14d
Days
Class 2
Risk

K060802 is an FDA 510(k) clearance for the VISUM LED SURGICAL LIGHTING SYSTEM. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Stryker Communications Corp. (Flower Mound, US). The FDA issued a Cleared decision on April 7, 2006 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.

FDA 510(k) Submission Details - K060802

510(k) Number K060802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2006
Decision Date April 07, 2006
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

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 73
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K060802.
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
OUTPATIENT III MINOR SURGERY LIGHT
K042395 · Burton Medical Products Corp. · Dec 2004
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
K042382 · Med-General Technologies, LLC · Nov 2004
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
K040735 · Alm S.A. · May 2004

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.

K060802 · VISUM LED SURGICAL LIGHTING SYSTEM
Download PDF FDA Summary Stryker Communication…