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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

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 .

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.

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