Cleared Special

K030142 - THERMACOOL TC SYSTEM

K030142 is an FDA 510(k) clearance for THERMACOOL TC SYSTEM, manufactured by Thermage, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 19-day FDA review.

K030142 · Thermage, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
19d
Days
Class 2
Risk

K030142 is an FDA 510(k) clearance for the THERMACOOL TC SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Thermage, Inc. (Hayward, US). The FDA issued a Cleared decision on February 3, 2003 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Thermage, Inc. devices

FDA 510(k) Submission Details - K030142

510(k) Number K030142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2003
Decision Date February 03, 2003
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1350
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K030142.
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
K021852 · Olympus Optical Co., Ltd. · Feb 2003
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K022856 · Aaron Medical Industries · Feb 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · Arthrocare Corp. · Feb 2003
BIPOLAR FORCEPS
K023813 · Richard Wolf Medical Instruments Corp. · Jan 2003
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
K023482 · Kirwan Surgical Products, Inc. · Jan 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · Erbe USA, Inc. · Jan 2003