ZELTIQ SYSTEM

K090094 · Zeltiq Aesthetics · GEX · May 20, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090094
• Device Name: ZELTIQ SYSTEM
• Applicant: Zeltiq Aesthetics
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zeltig System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite. Zeltiq Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.

Device Story

Zeltiq System is thermoelectric cooling/heating device; applies controlled thermal energy to treatment site. Includes optional electrically powered vibration or pulsatile vacuum massage; optional paging device. Uses Zeltiq Gel to improve thermal contact. Operated by clinicians in dermatological/surgical settings. Provides localized thermal therapy to minimize pain, relieve muscle spasms, improve circulation, and reduce cellulite appearance. Output is controlled thermal application and mechanical massage; assists clinical decision-making by providing non-invasive pain management and aesthetic support.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Thermoelectric cooling/heating device; electrically powered vibration or pulsatile vacuum massage; optional paging device. Uses Zeltiq Gel for thermal interface. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring skin cooling during laser/dermatological procedures, local anesthesia for minor discomfort, localized thermal therapy for post-traumatic/post-surgical pain, relief of minor aches/spasms, and temporary improvement in local circulation or reduction in cellulite appearance.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Zeltiq CLN1 Dermal Cooling Device (K080118)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko90094

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVE SECTION 6.

#### 6. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

r

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | Zeltiq Aesthetics, Inc.<br>4698 Willow Road<br>Pleasanton, CA 94588 | MAY 20 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------|
| TRADE NAME: | Zeltiq System | |
| COMMON NAME: | Skin Refrigerant | |
| CLASSIFICATION<br>NAME: | Laser instrument, surgical, powered | |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR §878.4810 | |
| PRODUCT CODE | 79 GEX - laser instrument, surgical, powered<br>89 IOL - pack, hot or cold, water circulating<br>89 ISA - massager, therapeutic, electric | |
| PREDICATE DEVICE: | The Zeltiq System is substantially equivalent to the Zeltiq<br>CLN1 Dermal Cooling Device (K080118) | |

## SUBSTANTIALLY EQUIVALENT TO:

The Zeltig System has the same intended use and mechanism of action to the Zeltig CLN1 Dermal Cooling Device (K080118).

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Zeltig System is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered or pulsatile vacuum massage and an optional paging device.

### INDICATION FOR USE:

The Zeltig System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.

2009

{1}------------------------------------------------

Ko 0.094

Page 2 of 2

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 6.

Zeltig Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.

# TECHNICAL CHARACTERISTICS:

The Zeltiq System is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The optional massage feature uses electrically powered vibration or pulsatile vacuum, depending on the applicator. The system includes an optional paging device.

# PERFORMANCE DATA:

ాను

Testing confirms that the Zeltiq System can be used in an equivalent manner to the predicate device.

# BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The indications for use for the Zeltiq System are the same as for the predicate device cited in this application. A technological comparison and bench testing demonstrate that the Zeltiq System is functionally equivalent to the predicate device.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

### Public Health Service

MAY 20 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zeltiq System % Mr. Donald V. Johnson VP. Operations, Regulatory and Quality Affairs 4698 Willow Road Pleasanton, California 94588

Re: K090094

Trade/Device Name: Zeltiq System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, ILO, ISA Dated: May 7, 2009 Received: May 11, 2009

Dear Mr. Johnson:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

{3}------------------------------------------------

Page 2 - Mr. Donald V. Johnson

[phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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. Melkerson
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

ר

Enclosure

{4}------------------------------------------------

# SECTION 5.

# INDICATIONS FOR USE STATEMENT

#### ડ. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Zeltig System

Indications for Use:

The Zeltig System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltig System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.

90094

Zeltiq Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.

Prescription Use . X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neile Roplem formkin

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page of

510(k) Number K.090014

K0900094 S-1