THERMAGE THERMACOOL SYSTEM

K043402 · Thermage, Inc. · GEI · Jan 14, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043402
• Device Name: THERMAGE THERMACOOL SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermage ThermaCool System is indicated for use in 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.

Device Story

The Thermage ThermaCool System is an electrosurgical device used for dermatologic and general surgical procedures. It utilizes a handpiece assembly with a treatment tip to deliver energy for electrocoagulation and hemostasis, as well as non-invasive treatment of facial and periorbital wrinkles. The system includes accessories such as a coolant canister, coupling fluid, return pad, skin marking paper, and an optional footswitch. It is operated by healthcare professionals in a clinical setting. The device functions by applying energy to tissue to achieve the desired surgical or aesthetic outcome. The system is designed to be substantially equivalent to previously cleared Thermage ThermaCool models.

Clinical Evidence

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

Technological Characteristics

Electrosurgical unit and accessories (21 CFR 878.4400). System includes handpiece assembly, treatment tip, coolant canister, coupling fluid, return pad, and skin marking paper. Operates via electrosurgical energy for coagulation and hemostasis.

Indications for Use

Indicated for patients requiring dermatologic and general surgical electrocoagulation and hemostasis, and for the non-invasive treatment of periorbital and facial 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 System (K040135)
• ThermaCool System (K033942)
• ThermaCool TC System (Model TC) (K021402)
• ThermaCool TC System (Model TC) (K013639)
• Thermage ThermaCool IIA System (K013034)
• Thermage ThermaCool II System (K003183)
• Thermage ThermaCool System (K000944)

Submission Summary (Full Text)

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JAN 1 4 2005

# 510(k) Safety Summary

# Name of Device A.

| Trade Name: | Thermage ThermaCool System Treatment Tip |
|----------------------|--------------------------------------------------------------------------------------|
| 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>Vice President of Regulatory/Clinical Affairs |

### B. Predicate Devices

ThermaCool TC System and Accessories:

| Device | Premarket Notification |
|---------------------------------|--------------------------|
| ThermaCool System | K040135, Cleared 6/21/04 |
| ThermaCool System | K033942, Cleared 2/4/04 |
| ThermaCool TC System (Model TC) | K021402, Cleared 11/5/02 |
| ThermaCool TC System (Model TC) | K013639, Cleared 1/29/02 |
| 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 |

# C. Device Description

The Thermage ThermaCool System consists of the following components:

- ThermaCool System ●
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .

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- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
- Accessory cables and tubing .
- Optional footswitch component .

#### D. Indicated Use

The Thermage ThermaCool System is indicated for use in 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.

#### E. Technical characteristics

The technological characteristics of the modified Thermage ThermaCool System Treatment Tip is substantially equivalent to those of the currently 510(k) cleared Thermage ThermaCool TC System Treatment Tips.

#### F. Summary

By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System Treatment Tip 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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

JAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, RN, MS Vice President of Regulatory/Clinical Affairs Thermage, Inc. 25881 Industrial Boulevard Hayward, California 94545

Re: K043402

Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 9, 2004 Received: December 10, 2004

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 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 M. Buckman, RN, MS

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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

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): K043402

Thermage ThermaCool System DEVICE NAME: INDICATIONS FOR USE:

The Thermage ThermaCool System is indicated for use in:

- The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis.
- Non-invasive treatment of periorbital wrinkles and rhytids. .
- Non-invasive treatment of facial wrinkles and rhytids. .

| Prescription Use | X |
|------------------|----------------------|
| OR | Over-The-Counter-Use |

| (Per 21 CFR 801.109) |
|--------------------------------------------------------|
| Concurrence of CDRH, Office of Device Evaluation (ODE) |

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices510(k) Number_________________________________________________________________________________________________________________________________________________________________