Cleared Traditional

CYNOSURE CELLULAZE LASER (K102541) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102541 · Cynosure, Inc. · General & Plastic Surgery device
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Jan 2012
Decision
510d
Days
Class 2
Risk

K102541 is an FDA 510(k) clearance for the CYNOSURE CELLULAZE LASER. Classified as Laser, Cellulite Appearance (product code OYW), Class II - Special Controls.

Submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 510 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Cynosure, Inc. devices

Submission Details

510(k) Number K102541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date January 26, 2012
Days to Decision 510 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
395d slower than avg
Panel avg: 115d · This submission: 510d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OYW Laser, Cellulite Appearance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition For The Removal Of Fat Through Laser Lipolysis.
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.