THERMAGE THERMACOOL TC SYSTEM

K021402 · Thermage, Inc. · GEI · Nov 5, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021402
• Device Name: THERMAGE THERMACOOL TC SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermage ThermaCool TC System (Model TC) is indicated for use in: Dermatologic and general surgical procedures for electrocoagulation and hemostasis, Non-invasive treatment of periorbital wrinkles and rhytids.

Device Story

Thermage ThermaCool TC System is an electrosurgical unit used in clinical settings by physicians. It delivers radiofrequency (RF) energy to tissue to achieve electrocoagulation and hemostasis, and for non-invasive treatment of periorbital wrinkles and rhytids. The system comprises an RF generator, cooling module, cryogen canister, handpiece assembly with treatment tip, and accessories including coupling fluid, return pad, and skin marking paper. The cooling module and cryogen canister provide surface cooling during RF delivery to protect the epidermis while heating deeper tissue layers. The physician operates the device via a handpiece and optional footswitch. The output is controlled RF energy; clinical benefit is achieved through thermal tissue modification for surgical hemostasis or aesthetic wrinkle reduction.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is based on design, principle of operation, and materials compared to previously cleared predicate devices.

Technological Characteristics

Electrosurgical unit utilizing radiofrequency (RF) energy. System includes RF generator, cooling module, cryogen canister, and handpiece. Accessories include return pad, coupling fluid, and skin marking paper. Operates via controlled thermal delivery to tissue.

Indications for Use

Indicated for patients requiring electrocoagulation and hemostasis during dermatologic and general surgical procedures, and for patients seeking non-invasive treatment of periorbital wrinkles and rhytids.

Regulatory Classification

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.

Predicate Devices

• ThermaCool (K000944)
• ThermaCool II (K003183)
• ThermaCool IIA (K013034)
• ThermaCool TC (K013639)
• Nikomed Electrosurgical Grounding Pad (K000079)
• Cadwell Lectron II (K933804)

Submission Summary (Full Text)

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021402

### 5 2002 NOV

2

#### 14.0 510(k) Safety Summary

,

#### A. Name of Device

| Trade Name: | Thermage ThermaCool TC System (Model TC) |
|----------------------|--------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and<br>Accessories (21 CFR 878.4400) |
| Contact Person: | Pamela M. Buckman, RN, MS<br>Sr. Director of Regulatory/Clinical Affairs |

#### B. Predicate Devices

ThermaCool TC System (including Cryogen canister and footswitch);

| 510 (k) Number | Name of Device | Decision Date |
|----------------|----------------|------------------|
| K000944 | ThermaCool | July 19, 2000 |
| K003183 | ThermaCool II | December 8, 2000 |
| K013034 (S) | ThermaCool IIA | October 4, 2001 |
| K013639 | ThermaCool TC | January 29, 2002 |

Other ThermaCool TC System Accessories (return pad, coupling fluid and skin marking paper):

| Accessory | Predicate | Premarket Notification |
|-----------------------|------------------------------------------|----------------------------|
| Return Pad | Nikomed Electrosurgical<br>Grounding Pad | K000079, Cleared 2/4/00 |
| Coupling Fluid | Cadwell Lectron II | K933804, Cleared 3/22/94 |
| Skin Marking<br>Paper | Skin Marker | Class I, Exempt (878.4660) |

# C. Device Description

The Thermage ThermaCool TC System consists of the following components:

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021402 4/2

- RF Generator
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- . Accessory cables and tubing
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .

The Handpiece Assembly and Cooling Module connect to the RF Generator.

#### D. Indicated Use

The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis; noninvasive treatment of periorbital wrinkles and rhytids.

#### E. Technical characteristics

The technological characteristics and clinical use data of the Thermage ThermaCool TC System for the expanded indication are substantially equivalent to those of ThermaCool II System, and the previously cleared ThermaCool TC System.

#### F. Summary

By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool TC System is substantially equivalent to devices currently cleared for marketing in the United States.

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### NOV 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, R.N., M.S. Senior Director of Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545

## Re: K021402

Trade/Device Name: Thermage ThermaCool TC System (Model TC) Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 5, 2002 Received: August 6, 2002

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Pamela M. Buckman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the . regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Co Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEVICE NAME: Thermage ThermaCool TC System (Model TC)

K021402

INDICATIONS FOR USE:

The Thermage ThermaCool TC System (Model TC) is indicated for use in:

Dermatologic and general surgical procedures for electrocoagulation and hemostasis,

Non-invasive treatment of periorbital wrinkles and rhytids ﻨﻪ ﺳ

Miriam C. Provost

(Division Sign-Off) (Division Sign-Oir)
Division of General, Restorative Division ological Devices

510(k) Number K 021402

Thermage ThermaCool TC System 510(k)