Cleared Special

K043429 - CYNERGY LASER

K043429 is the FDA 510(k) clearance for CYNERGY LASER by Cynosure, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Special 510(k) pathway after a 30-day FDA review.

K043429 · Cynosure, Inc. · General & Plastic Surgery device
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Jan 2005
Decision
30d
Days
Class 2
Risk

K043429 is an FDA 510(k) clearance for the CYNERGY 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 January 12, 2005 after a review of 30 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cynosure, Inc. devices

Submission Details

510(k) Number K043429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date January 12, 2005
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K043429.
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K050021 · Vascular Solutions, Inc. · Mar 2005
VAPORMAX
K050412 · Trimedyne, Inc. · Mar 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
K043251 · Candela Corp. · Feb 2005
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · Nidek, Inc. · Dec 2004
CANDELA SMOOTHBEAM LASER SYSTEM
K041242 · Candela Corp. · Nov 2004
OMNIPULSE MINI, MODEL 2120
K043012 · Trimedyne, Inc. · Nov 2004