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K Number
K051710
Device Name
THERMAGE THERMACOOL COUPLING FLUID
Manufacturer
THERMAGE, INC.
Date Cleared
2005-07-19

(22 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K033942
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 u hemostasis,
  • Non-invasive treatment of periorbital wrinkles and rhytids u
  • 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

This document, K051710, is a 510(k) premarket notification for the Thermage ThermaCool System and primarily focuses on the substantial equivalence of its coupling fluid to a previously cleared predicate device. It defines the product and its intended use but does not contain information about acceptance criteria or a study proving the device meets said criteria.

The provided text only includes:

  • Device Name: Thermage ThermaCool System
  • Common Name: Electrosurgical Unit and Accessories
  • Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400)
  • Indicated Uses:
    • Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
    • Non-invasive treatment of periorbital wrinkles and rhytids.
    • Non-invasive treatment of facial wrinkles and rhytids.
  • Predicate Device for the Coupling Fluid: Thermage ThermaCool Coupling Fluid TF-2 (K033942, Cleared 2/4/04)

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

§ 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.