THERMAGE THERMACOOL COUPLING FLUID

K051710 · Thermage, Inc. · GEI · Jul 19, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051710
• Device Name: THERMAGE THERMACOOL COUPLING FLUID
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 19, 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

Thermage ThermaCool System is an electrosurgical unit used for electrocoagulation, hemostasis, and non-invasive wrinkle treatment. System components include a main unit, handpiece assembly with treatment tip, coolant canister, coupling fluid, return pad, skin marking paper, and optional footswitch. The device is operated by clinicians in a clinical setting. The coupling fluid acts as an interface between the treatment tip and the skin to facilitate energy delivery. By applying controlled electrosurgical energy, the device enables tissue coagulation and hemostasis, while non-invasive treatment of wrinkles is achieved through thermal effects on skin tissue. The healthcare provider uses the system to perform dermatologic and surgical procedures, potentially improving patient aesthetic outcomes regarding facial and periorbital rhytids.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, materials, and principle of operation.

Technological Characteristics

Electrosurgical unit (21 CFR 878.4400). System includes handpiece, treatment tip, coolant canister, coupling fluid, and return pad. Operates via electrosurgical energy for coagulation and hemostasis. Coupling fluid serves as a conductive interface.

Indications for Use

Indicated for patients requiring electrocoagulation and hemostasis in dermatologic and general surgical procedures, 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 Coupling Fluid TF-2 (K033942)

Submission Summary (Full Text)

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051710

# 510(k) Safety Summary 14.0

# Name of Device A.

| Trade Name: | Thermage ThermaCool System |
|----------------------|--------------------------------------------------------------------------------------|
| 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 |

# Predicate Devices B.

The predicate device for the ThermaCool Coupling Fluid that is the subject of this 510(k) is:

| Accessory | Predicate | Premarket Notification |
|----------------|--------------------------------|-------------------------|
| Coupling Fluid | ThermaCool Coupling Fluid TF-2 | K033942, Cleared 2/4/04 |

### Device Description C.

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 .

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#### D. Indicated Use

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

# Technical characteristics E.

The technological characteristics of the ThermaCool Coupling Fluid is substantially equivalent to those of the predicate device.

#### F. Summary

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, RN, MS VP Clinical/Regulatory Thermage, Inc. 4058 Point Eden Way Hayward, California 94545-3721

Re: K051710

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: July 7, 2005 Received: July 8, 2005

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section - Forty premained in substantially equivalent (for the indications referenced above and nave uctchillied the devices marketed in interstate for use stated in the encrosule for legally manities in the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactions and the Federal Food. Drug. devices that have been reclassified in accenance with the providions of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general masistentian, You may, merelore, market the dovres, belyer to in of any in any intereststration, listing of
general controls provisions of the Act include requirements for any interestran general controls provisions of the fret mercials requires 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 classifica (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entrolling Component of Commons, Time of September of be found in the Code of Peachar Regerning 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 backan and mith other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has inade a determination administered by other Federal agencies. You must of any Federal statutes and regulations adminders on thot limited to: registration and listing (21 l comply with an the Act 31cquiroments, merceing, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 11 app 1050 forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

JUL 1 9 2005

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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 10(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket nothcation. THC PDA miding of backed on 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 If you desire specific advice for your ac now on 5. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note Colliation of Compulation and (21 the Part 807.97). You may obtain Misorahung by icierchoe to premainsonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provo

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koś 1710

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

Thermage ThermaCool System DEVICE NAME: INDICATIONS FOR USE: ستقرميترت التق

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

| Prescription Use | <b>X</b> | OR | | Over-The-Counter-Use | |
|--------------------------------------------------------|----------|----|--|----------------------|--|
| (Per 21 CFR 801.109) | | | | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | | |
| (Division Sign- | | | | | |
| Division of Ger 1. Restorative | | | | | |
| and from J. J. Devices | | | | | |
| 510(k) Number: K051710 | | | | | |

Thermage ThermaCool Coupling Fluid 510(k)