Cleared Traditional

K102758 - TRULIGHT 5520 AND TRULIGHT 5320

K102758 is an FDA 510(k) clearance for TRULIGHT 5520 AND TRULIGHT 5320, manufactured by Trumpf Kreuzer Medizin Systeme 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 33-day FDA review.

K102758 · Trumpf Kreuzer Medizin Systeme 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
Oct 2010
Decision
33d
Days
Class 2
Risk

K102758 is an FDA 510(k) clearance for the TRULIGHT 5520 AND TRULIGHT 5320. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (Charleston, US). The FDA issued a Cleared decision on October 26, 2010 after a review of 33 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 - K102758

510(k) Number K102758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date October 26, 2010
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
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 Peers - FSY Light, Surgical, Ceiling Mounted

All 69
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K102758 · TRULIGHT 5520 AND TRULIGHT 5320
Download PDF FDA Summary Trumpf Kreuzer Medizi…