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K Number
K053365
Device Name
MODIFICATION TO THERMAGE THERMACOOL SYSTEM
Manufacturer
THERMAGE, INC.
Date Cleared
2005-12-13

(11 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Thermage ThermaCool System is indicated for use in:

  • Dermatologic and general surgical procedures for electro coagulation and hemostasis
  • Non-invasive treatment of wrinkles and rhytids
Device Description

This special 510(k) application covers a system identical to the earlier devices and clearances.
The Thermage ThermaCool System consists of the following components:
*RF Generator
*Cooling Module
*Cryogen Canister
*Handpiece Assembly (consisting of Handpicce and Treatment Tip)

  • Accessory cables and tubing
    *Optional footswitch component
  • Accessories: coupling fluid, return pad and skin marking paper
AI/ML Overview

The provided text describes a 510(k) premarket notification for the Thermage ThermaCool System, focusing on its substantial equivalence to a predicate device and its indications for use. It does not contain information about acceptance criteria, device performance, study design, or ground truth establishment.

Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report.

§ 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.