MODIFICATION TO THERMAGE THERMACOOL SYSTEM

K072849 · Thermage, Inc. · GEI · Jan 18, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072849
• Device Name: MODIFICATION TO THERMAGE THERMACOOL SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 18, 2008
• 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 including upper and lower eyelids Non-invasive treatment of wrinkles and rhytids Temporary improvement in the appearance of cellulite Relief of minor muscle aches and pains Relief of muscle spasms Temporary improvement of local circulation (i.e., blood circulation)

Device Story

ThermaCool NXT Multiplex Assembly is an electrosurgical accessory for the Thermage ThermaCool System. Device features a 4-electrode design with 3.00-cm footprints and a ceramic coolant spreader. Input consists of electrical energy delivered to tissue; device transforms this into controlled thermal energy for electrocoagulation and hemostasis. Used in clinical settings by physicians for non-invasive dermatologic procedures, including wrinkle reduction and cellulite improvement. Modified handpiece, coupling fluid, return pad, and skin marking paper accommodate larger tip dimensions. Output is thermal effect on tissue; provider monitors clinical response to adjust treatment. Benefits include non-invasive aesthetic improvement and symptomatic relief of muscle-related pain.

Clinical Evidence

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

Technological Characteristics

Electrosurgical accessory; 4-electrode design with 3.00-cm footprints; ceramic coolant spreader; modified handpiece, coupling fluid, return pad, and skin marking paper. Operates via electrical energy for electrocoagulation/hemostasis. Materials are consistent with previously cleared tips.

Indications for Use

Indicated for patients requiring dermatologic and general surgical electrocoagulation and hemostasis, treatment of periorbital and general wrinkles/rhytids, temporary cellulite appearance improvement, relief of minor muscle aches/pains/spasms, and temporary improvement of local blood circulation.

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 (Model NXT) (K033942)
• ThermaCool System (K032088)
• ThermaCool System (K031046)
• ThermaCool System (K043402)
• ThermaCool System (K051710)
• ThermaCool System (K052778)

Submission Summary (Full Text)

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K072849

# 14.0 510(k) Safety Summary

#### Name of Device A.

| Trade Name: | ThermaCool NXT Multiplex Assembly |
|----------------------|--------------------------------------------------------------------------------------|
| 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 Device B.

| Predicate Devices | Premarket Notification Number |
|------------------------------------------------------------------------------------|-------------------------------|
| Components and accessories<br>compatible with the ThermaCool<br>System (Model NXT) | K033942 |
| | K032088 |
| | K031046 |
| | K043402 |
| | K051710 |
| | K052778 |

# C. Device Description

The Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.

# D. Indicated Use

The Thermage ThermaCool NXT Multiplex Assembly, including accessories and all components, is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hernostasis, non-invasive treatment of periorbital wrinkles and rhytids including upper and lower evelids, non invasive treatment of wrinkles and rhytids, temporary improvement in the appearance of cellulite, temporary improvement in local circulation, i.e., blood circulation, relief of minor muscle aches and pains, relief of muscle spasms.

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0728419

# E. Technical characteristics

The technological characteristics of the Multiplex Assembly, components and accessories are substantially equivalent to those of the standard NXT Assembly, components and accessories.

# F. Summary

By virtue of design, principle of operation, materials and intended use, the Multiplex Assembly is substantially equivalent to 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

# Public Health Service

JAN 1 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072849

Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: January 14 2008 Received: January 15, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N Millerson

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

Ko72849 510(k) NUMBER (IF KNOWN):

DEVICE NAME:

Thermage ThermaCool System

INDICATIONS FOR 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 including upper and lower eyelids

Non-invasive treatment of wrinkles and rhytids

Temporary improvement in the appearance of cellulite

Relief of minor muscle aches and pains

Relief of muscle spasms

Temporary improvement of local circulation (i.e., blood circulation)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR Over-The-Counter-Use
Laubara Buem

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K072841