Cleared Traditional

K032539 - CYNOSURE PHOTOGENICA SV LASER

K032539 is the FDA 510(k) clearance for CYNOSURE PHOTOGENICA SV LASER by Cynosure, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K032539 · Cynosure, Inc. · General & Plastic Surgery device
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Nov 2003
Decision
91d
Days
Class 2
Risk

K032539 is an FDA 510(k) clearance for the CYNOSURE PHOTOGENICA SV LASER. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Cynosure, Inc. (Chelmsford, US). The FDA issued a Cleared decision on November 17, 2003 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cynosure, Inc. devices

Submission Details

510(k) Number K032539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2003
Decision Date November 17, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 986
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K032539.
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · Candela Corp. · Dec 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
K033237 · Vascular Solutions, Inc. · Nov 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · Laserscope · Nov 2003
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
K033172 · Candela Corp. · Oct 2003
CYNOSURE PHOTOGENICA VL
K032565 · Cynosure, Inc. · Oct 2003
CYNOSURE SMART FILE ND:YAG LASERS
K031125 · Cynosure, Inc. · Oct 2003