THERMAGE THERMACOOL TC SYSTEM

K013639 · Thermage, Inc. · GEI · Jan 29, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013639
• Device Name: THERMAGE THERMACOOL TC SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Device Story

The Thermage ThermaCool TC System is an electrosurgical unit used in dermatologic and general surgical procedures. It consists of an RF generator, coolant control center, coolant canister, handpiece assembly (handpiece and treatment tip), and accessories including a return pad, coupling fluid, and skin marking paper. The device delivers radiofrequency (RF) energy to tissue to achieve electrocoagulation and hemostasis. It is operated by healthcare professionals in a clinical setting. The system utilizes a cooling mechanism to manage thermal effects during energy delivery. The output is controlled by the clinician to perform surgical coagulation, aiding in the management of bleeding during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, technological characteristics, and intended use compared to predicate devices.

Technological Characteristics

Electrosurgical unit utilizing RF energy for coagulation and hemostasis. System components include RF generator, coolant control center, handpiece, and accessories (return pad, coupling fluid). Operates via RF energy delivery with integrated cooling. Materials include standard medical-grade components for electrosurgical accessories.

Indications for Use

Indicated for use in dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

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

• Thermage ThermaCool IIA System (K013034)
• Thermage ThermaCool II System (K003183)
• Thermage-ThermaCool System (K000944)
• Nikomed Electrosurgical Grounding Pad (K000079)
• Cadwell Lectron II (K933804)

Submission Summary (Full Text)

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# JAN 2 9 2002

K013639

# 510(k) Safety Summary 14.0

## Name of Device A.

| 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 | |

#### Predicate Devices B.

ThermaCool TC System (including coolant canister and footswitch:

| Device | Premarket Notification |
|--------------------------------|--------------------------|
| Thermage ThermaCool IIA System | K013034, Cleared 10/4/01 |
| Thermage ThermaCool II System | K003183, Cleared 12/8/00 |
| Thermage-ThermaCool System | K000944, Cleared 7/19/00 |

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) |

#### Device Description C.

The Thermage ThermaCool TC System consists of the following components:

- RF Generator .
- Coolant Control Center ●
- Coolant 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 Coolant Control Center connect to the RF Generator.

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### Indicated Use D.

The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

#### Technical characteristics E.

The technological characteristics of the Thermage ThermaCool TC System are substantially equivalent to those of the Thermage ThermaCool IIA System, ThermaCool II System, and ThermaCool 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

JAN 2 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, RN, MS Sr. Director of Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545-3721

Re: K013639

Trade Name: Thermage Thermacool TC System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 2, 2002 Received: November 5, 2001

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 set forth in the quality systems (QS) 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 Buckman

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxeming your antial equivalence of your device to a legally premarket nothication: "The PDF micing of casification 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 II you desire specific au rio for you avitro diagnostic devices), please contact the Office of additionally 21 CT F Fatt 607.10 for questions on the promotion and advertising of Compliance at [phone]. Thenker Compliance at [phone]. Also, please note the your device, prodo combranding by reference to premarket notification™ (21CFR Part 807.97). It general information on your responsibilities under the Act may be obtained from the Other general information on your respectional 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,

/ Mark n Millan

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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510(k) NUMBER (IF KNOWN):

Thermage ThermaCool TC System (Model TC)

INDICATIONS FOR USE:

DEVICE NAME:

The Thermage ThermaCool TC System (Model TC) is indicated for use in Dermatologic The Thermage Thematoon To 65 electrocoagulation and hemostasis.

K013639

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Thermage ThermaCool TC System 510(k)
510(k) Number. K013639

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