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ThermaCool TC System

by Thermage, Inc. 2 variants

510(k) K030142

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK030142 Date3 Feb 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ThermaCool TC System is a Class 2 general and plastic surgery device with product code GEI. It is indicated for non-invasive treatment of periorbital rhytids and wrinkles, and for dermatologic and general surgical procedures involving electrocoagulation and hemostasis.

The device is manufactured by Thermage, Inc. in accordance with defined specifications. It received FDA 510(k) clearance (K030142) through the Special pathway on February 3, 2003, following a 19-day review. The device is supplied as a system accessory for use in clinical settings.

Other devices from Thermage, Inc.

See all devices from Thermage, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ThermaCool TC System used for?

    The ThermaCool TC System is indicated for non-invasive treatment of periorbital rhytids and wrinkles, and for dermatologic and general surgical procedures involving electrocoagulation and hemostasis, as stated in its device description.

  • How is the ThermaCool TC System supplied for clinical use?

    The device is supplied as a system accessory for use in clinical settings, manufactured by Thermage, Inc. in accordance with defined specifications.

  • What regulatory pathway was used for the ThermaCool TC System's FDA clearance?

    The ThermaCool TC System received FDA 510(k) clearance through the Special pathway on February 3, 2003, following a 19-day review after submission on January 15, 2003.