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K Number
K043402
Device Name
THERMAGE THERMACOOL SYSTEM
Manufacturer
THERMAGE, INC.
Date Cleared
2005-01-14

(35 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K040135,K033942,K021402,K013639,K013034,K003183,K000944
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Thermage ThermaCool System is indicated for use in:

  • The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis.
  • Non-invasive treatment of periorbital wrinkles and rhytids. .
  • Non-invasive treatment of facial wrinkles and rhytids. .
Device Description

The Thermage ThermaCool System consists of the following components:

  • ThermaCool System ●
  • Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
  • Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
  • Accessory cables and tubing .
  • Optional footswitch component .
AI/ML Overview

The provided document is a 510(k) Safety Summary for the Thermage ThermaCool System Treatment Tip, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

The document focuses on:

  • Identifying the device and its classification.
  • Listing predicate devices.
  • Describing the device components and its intended uses.
  • Stating that its technical characteristics are "substantially equivalent" to cleared predicate devices.
  • Confirming FDA's substantial equivalence determination.

Therefore, I cannot provide the requested information, as it is not present in the given text.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.