THERMAGE THERMACOOL SKIN MARKETING

K052778 · Thermage, Inc. · GEI · Oct 20, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052778
• Device Name: THERMAGE THERMACOOL SKIN MARKETING
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 20, 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 electro coagulation 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 in dermatologic and general surgical procedures. System components include a main unit, handpiece assembly with treatment tip, coolant canister, coupling fluid, return pad, and skin marking paper. Device operates by delivering energy to tissue to achieve electrocoagulation and hemostasis; also used for non-invasive wrinkle reduction. Operated by clinicians in a clinical setting. Skin marking paper is used to guide the treatment application. System provides therapeutic benefit through controlled thermal effects on skin tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Electrosurgical unit (21 CFR 878.4400). System includes handpiece, treatment tip, coolant delivery, and skin marking accessories. Operates via electrocoagulation/hemostasis principle. Class II device.

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis, and for the non-invasive treatment of periorbital and facial wrinkles and rhytids in adult patients.

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 Skin Marking Paper (K032088)

Submission Summary (Full Text)

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# 510(k) Safety Summary 14.0

OCT 2 0 2005

## 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 Skin Marking Paper that is the subject of this 510(k) is:

| Accessorv | Predicate | Premarket Notification |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Skin Marking Paper ThermaCool Skin Marking Paper<br>Acres and of a free shoulded in of Chind Chief Child Child Child Child Child Child Child Children Mill 141 Me 11807 Million Comments | K032088, Cleared 8/01/03 |

### 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 .

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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 treatment of periorbital wrinkles and rhytids. Non-invasive treatment of facial wrinkles and rhytids.

#### Technical characteristics E.

The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device.

#### F. Summary

By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool Skin Marking Paper 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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OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pamela M. Buckman, RN, MS Vice President of Regulatory/Clinical Affairs Thermage, Inc. 25881 Industrial Boulevard Hayward, California 94545-2991

Re: K052778

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: September 30, 2005 Received: October 3, 2005

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abounded in 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). and cooming the efect 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 adultcration.

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 mary of 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 HDA has made a determination that your device complics 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- Pamela M. Buckman, RN, MS

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maining of substantial equivalence of your device to a legally prematication: The PDF intentigation 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 IT you desire specific at no 10-10-1 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 other general 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.

Barbara Buchner
for

Mark N. Melkerson Acting 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 K052778 510(k) NUMBER (IF KNOWN):

Thermage ThermaCool™ System DEVICE NAME:

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 .
- 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)

*[Signature]*
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Thermage ThermaCool Skin Marking Paper 510(k)

| 510(k) Number | K052778 |
|---------------|---------|
|---------------|---------|

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