THERMAGE THERMACOOL SYSTEM

K052936 · Thermage, Inc. · GEI · Jun 12, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K052936
• Device Name: THERMAGE THERMACOOL SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 12, 2007
• 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 electro coagulation and hemostasis, - Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids - Non-invasive treatment of facial wrinkles and rhytids

Device Story

Thermage ThermaCool System is an electrosurgical unit for non-invasive skin tightening and wrinkle reduction. System components include main console, handpiece assembly with treatment tip, coolant canister, coupling fluid, return pad, and skin marking paper. Device delivers radiofrequency energy to tissue to induce thermal effects; used in clinical settings by trained professionals. Output is controlled thermal energy for electrocoagulation and hemostasis; clinical benefit includes non-invasive reduction of periorbital and facial rhytids. Healthcare providers use the system to treat skin laxity; requires use of commercially available eyeshields for periorbital procedures.

Clinical Evidence

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

Technological Characteristics

Electrosurgical unit (21 CFR 878.4400). System includes console, handpiece, treatment tip, coolant, and return pad. Energy source: Radiofrequency. Connectivity: Standalone. Sterilization: Not specified. Software: Not specified.

Indications for Use

Indicated for patients requiring dermatologic and general surgical electrocoagulation and hemostasis, and non-invasive treatment of facial and periorbital wrinkles and rhytids, including upper and lower eyelids.

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 (K043042)
• Lumenis Family of UltraPulse SurgiTouch CO, Surgical Lasers (K030147)

Submission Summary (Full Text)

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# Ko 52996 14.0 510(k) Safety Summary

### A. Name of Device

| 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 |

## B. Predicate Devices

:

The predicate devices for the ThermaCool System for Eyelid Indication that is the subject of this 510(k) are:

| Predicate | Premarket Notification |
|----------------------------------------------------------------|------------------------|
| ThermaCool System | K043042, et al. |
| Lumenis Family of UltraPulse<br>SurgiTouch CO, Surgical Lasers | K030147 |

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5 2936

#### C. Device Description

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 ●

#### D. Indication for Use

The Thermage ThermaCool System for the new indication is: Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids.

#### E. Technical characteristics

The technological characteristics of the Thermage ThermaCool System for Eyelid Indications are identical to the cleared system. The required eyeshield is a commercially available device and is not the subject of this 510(k).

#### F. Summary

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thermage, Inc. % Ms. Pamela M. Buckman, MSN VP, Clinical/Regulatory 25881 Industrial Boulevard Hayward, California 94545-2991

[JUN 1 2 2007

Re: K052936

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: March 13, 2007 Received: March 14, 2007

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, MSN

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/industry/support/index.html.

Sincerely yours

foe

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

Enclosure

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# 2.0 Indications for Use Statement

K052936

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

DEVICE NAME: Thermage ThermaCool System 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 periorbital wrinkles and rhytids including the upper and ■ lower eyelids
- Non-invasive treatment of facial wrinkles and rhytids

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

**510(k) Number** K052936

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(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)