Cleared Special

K073394 - SMARTLIPO LASER

K073394 is an FDA 510(k) clearance for SMARTLIPO LASER, manufactured by Cynosure, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 9-day FDA review.

K073394 · Cynosure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
9d
Days
Class 2
Risk

K073394 is an FDA 510(k) clearance for the SMARTLIPO 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. (Wesford, US). The FDA issued a Cleared decision on December 12, 2007 after a review of 9 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.

FDA 510(k) Submission Details - K073394

510(k) Number K073394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date December 12, 2007
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

GEX Device Classification - Class 2, Special Controls

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 2870
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K073394.
CYNOSURE YAG FAMILY LASER
K072484 · Cynosure, Inc. · Dec 2007
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
K072995 · Lumen Development and Manufacturing, Inc. · Dec 2007
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K073409 · Omniguide, Inc. · Dec 2007
MILESMAN PREMIUM
K073300 · Milesman S.L. · Dec 2007
APL MEDICAL SYSTEM
K072344 · Bios S.R.L. · Dec 2007
NOVEON, MODEL LS1100-01-0968
K071815 · Nomir Medical Technologies, Inc. · Nov 2007
K073394 · SMARTLIPO LASER
Download PDF FDA Summary Cynosure, Inc.