Cleared Special

K031184 - COOL TOUCH 3

K031184 is the FDA 510(k) clearance for COOL TOUCH 3 by New Star Lasers, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Special 510(k) pathway after a 36-day FDA review.

K031184 · New Star Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
36d
Days
Class 2
Risk

K031184 is an FDA 510(k) clearance for the COOL TOUCH 3. 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 May 21, 2003 after a review of 36 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

Submission Details

510(k) Number K031184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2003
Decision Date May 21, 2003
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 1350
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K031184.
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
K031233 · AngioDynamics, Inc. · Jun 2003
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
K031488 · Cynosure, Inc. · Jun 2003
SMART 2940 D ER: YAG LASER
K031317 · Cynosure, Inc. · May 2003
COOLTOUCH ND: YAG LASER SYSTEM
K030453 · New Star Lasers, Inc. · May 2003
SMARTXIDE
K031224 · Cynosure, Inc. · May 2003
ARAMIS II DERMATOLOGICAL LASER
K023734 · Quantel Medical · May 2003