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.

Summary

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DEC 1 3 2005

K053365

510(k) Summary Information	THERMAGE, INC.
Premarket Notification, Section 510(k)	NOVEMBER 28, 2005

Pursuant to the Safe Medical Devices Act of 1990, 21 CFR 807.92

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

Thermage ThermaCool System Trade Name:

Common

Electrosurgical cutting and coagulation device Name(s):

Classification

Electrosurgical cutting and coagulation device Name(s):

Establishment Name & Registration Number:

THERMAGE, INC. Name: Number:

Classification(s):

$ 878.4400 Electrosurgical cutting and coagulation device and accessories.

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. Classification. Class II.

Class II for all requested indications Device Class: Classification Panel: General and Plastic Surgery Product Code(s): GEI

Equivalent Predicate Device:

The Thermage ThermaCool System is substantially identical to the following device system:

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

Indications for Use:

The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical I in Thermige Thermicone bysten 'no hemostasis. Non-invasive treatment of wrinkles & rhytids.

Applicant Name & Address:

Thermage, Inc. 25881 Industrial Blvd. Hayward, CA 94545-2991 510 782 2286 voice 510 782 2287 fax

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing three abstract shapes, possibly representing support or care.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2005

Ms. Pamela M. Buckman, RN, MS V. P. Clinical & Regulatory Affairs Thermage, Inc. 25881 Industrial Blvd. Hayward, California 94545-2991

Re: K053365

K055565
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Number: 21 CFN 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 30, 2005 Received: December 2, 2005

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IV(E) prematice is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regary manced to concel Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessment opprovisions of the Act . T and Cosmetic Act (Act) that do not require approved controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general registrat You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mende requirement.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio entire cass in engelations affecting your device can
may be subject to such additional controls. Existing major regulations alle may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regalations, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a substance only other requirements of the Act
that FDA has made a determination that your device Edgeral of our must that FDA has made a delectimation administered by other Federal agencies. You must or any Federal statutes and regulations administered to: registration and listing (21 largestration and listing (21 l comply with all the Act s requirements, incriating practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Part 800); god analysis (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat); 21 CFR 1000-1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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Page 2 - Ms. Buckman

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegill maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vou premarket notification. The FDA inding of substantial required in thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rstilled If you desire specific advice for your device of your accesse note the regulation entitled, the more abtain contact the Office of Complaned at (216) 276-6101" (21CFR Part 807.97). You may obtain "Misbranding by reletence to premantel routhead.com the Act from the Division of Small other general Information on your responsion Assistance at its toll-free number (800) 638-2041 or and Manufacturers, International and Collsuner Flosbuller Flosbules and Consult industry/support/index.html

Sincerely yours,

barbay Buehup

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOS3361 Not Known 510(k) NUMBER (IF KNOWN):

Thermage ThermaCool System DEVICE NAME:

INDICATIONS FOR 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 L

And American---------------------------------------------------------------------------Prescription Use------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Second a " . " . " . "	-------------------------------------------------------------------------------	OPc------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Over-The-Counter-Use.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------	--

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shalane Buehl
Division Sign-Off

Division of General, Restorative and Neurological Devices

Special 510(k)ThermaCool.doc

510(k) Number. K053365

Regulation Number and Section

§ 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.