Cleared Traditional

K062210 - COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160

K062210 is an FDA 510(k) clearance for COOL TOUCH, manufactured by New Star Lasers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K062210 · New Star Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
55d
Days
Class 2
Risk

K062210 is an FDA 510(k) clearance for the COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160. 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 September 25, 2006 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New Star Lasers, Inc. devices

FDA 510(k) Submission Details - K062210

510(k) Number K062210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date September 25, 2006
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K062210.
SMARTLIPO ND:YAG LASER
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TATTOOSTAR FAMILY
K060787 · Asclepion Laser Technologies GmbH · Sep 2006
COOLTOUCH, MODEL CTEV
K061618 · New Star Lasers, Inc. · Sep 2006
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K061455 · Dornier Medtech America, Inc. · Aug 2006
DENLASER 800 PLUS
K061366 · CAO Group, Inc. · Jul 2006
LUMENIS ONE FAMILY OF SYSTEMS
K060448 · Lumenis, Ltd. · Jul 2006