Cleared Special

K072424 - COOLTOUCH, MODEL LC215,COOLLIPO

K072424 is an FDA 510(k) clearance for COOLTOUCH, manufactured by New Star Lasers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 35-day FDA review.

K072424 · New Star Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
35d
Days
Class 2
Risk

K072424 is an FDA 510(k) clearance for the COOLTOUCH, MODEL LC215,COOLLIPO. 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 New Star Lasers, Inc. (Roseville, US). The FDA issued a Cleared decision on October 3, 2007 after a review of 35 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 New Star Lasers, Inc. devices

FDA 510(k) Submission Details - K072424

510(k) Number K072424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2007
Decision Date October 03, 2007
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 1763
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K072424.
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
K071051 · Reliant Technologies, Inc. · Nov 2007
GENTLERAY 980 DIODE LASER SYSTEM
K072262 · Kavo America · Oct 2007
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
K071621 · Reliant Technologies, Inc. · Oct 2007
VISULAS TRION
K072514 · Carl Zeiss Meditec, AG · Sep 2007
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
K072034 · Quanta System Spa · Sep 2007
150W CERALAS D 980NM DIODE LASER
K072106 · Biolitec, Inc. · Aug 2007