JUNIPER COOLING DEVICE XTRA

K063715 · Juniper Medical, Inc. · GEX · Feb 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063715
• Device Name: JUNIPER COOLING DEVICE XTRA
• Applicant: Juniper Medical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Juniper Cooling Device XTRA 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 Juniper Cooling Device XTRA 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 relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite. The Juniper Medical Coupling Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.

Device Story

Device provides localized thermal therapy (hot/cold) and massage; used to minimize pain/thermal injury during laser/dermatological procedures or for post-traumatic/post-surgical pain relief. Operates via thermal contact with patient skin, facilitated by optional coupling gel to ensure consistent contact. Used in clinical settings; operated by healthcare professionals. Output is physical thermal energy (cooling/heating) and mechanical massage action. Benefits include pain reduction, local anesthetic effect, muscle spasm relief, improved circulation, and temporary cellulite reduction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics and intended use to legally marketed predicate devices.

Technological Characteristics

Thermal therapy device providing hot/cold application and massage. Includes optional coupling gel. Class II device under 21 CFR 878.4810. Operates as a powered surgical/therapeutic instrument. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring skin cooling to minimize pain/thermal injury during laser/dermatological procedures, local anesthesia for minor discomfort, localized thermal therapy (hot/cold) for post-traumatic/post-surgical pain, relief of minor aches/pains/muscle spasms, and massage for muscle relief, improved local circulation, and temporary cellulite reduction.

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

• Juniper Cooling Device (K060407)
• MediSeb's ElfCare thermal therapy device (K023231)
• Cynosure Triactive Therapeutic massager (K030876)

Reference Devices

• Thermage ThermaCool System (K05170)
• Pharmaceutical Innovation's Eyron Gel (K961222)

Submission Summary (Full Text)

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#### SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K 063715

#### 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

. .

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 | Juniper Medical, Inc.<br>7139 Koll Center Parkway, Suite 300<br>Pleasanton, CA 94566 | | | | | FEB 05 2007 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|-------------|
| TRADE NAME: | Juniper Cooling Device | | | | | |
| 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 Juniper Cooling Device XTRA is substantially<br>equivalent in intended use and mechanism of action to the<br>Juniper Cooling Device (K060407) and the MediSeb's<br>ElfCare thermal therapy device for both hot and cold<br>applications (K023231, cleared on April 4th, 2003). The<br>device is also substantially equivalent to the Cynosure<br>Triactive Therapeutic massager (K030876). Also included<br>in this submission is the Juniper Medical Coupling Gel,<br>which is intended to be supplied as an optional consumable<br>supply. The gel is substantially equivalent in intended use<br>and mechanism of action to the coupling fluid provided<br>optionally with the Thermage ThermaCool System<br>(K05170), and is substantially equivalent in composition to<br>Pharmaceutical Innovation's Eyron Gel (K961222) | | | | | |

# SUBSTANTIALLY EQUIVALENT TO:

The Juniper Cooling Device XTRA is substantially equivalent in intended use and mechanism of action to the Juniper Cooling Device (K060407) and the MediSeb's ElfCare thermal therapy device for both hot and cold applications (K023231, cleared on April 44, 2003). The device is also substantially equivalent to the Cynosure Triactive Therapeutic massager (K030876). Also included in this submission is the Juniper Medical Coupling Gel, which is intended to be supplied as an optional consumable

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Juniper Medical, Inc. % Mr. Don Johnson Vice President, Regulatory, Clinical & Quality Affairs 7139 Koll Center Parkway Suite 300 Pleasanton, California 94566

FEB 5 2007

Re: K063715

Trade/Device Name: Juniper Cooling Device XTRA 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: December 13, 2006 Received: December 14, 2006

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.

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

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Page 2 – Mr. Don Johnson

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.

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,

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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# SECTION 4.

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 长 063715

Device Name: Juniper Cooling Device XTRA

Indications for Use:

The Juniper Cooling Device XTRA 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 Juniper Cooling Device XTRA 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 relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.

The Juniper Medical Coupling Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | x | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, ^Page of

and Neurological Devices

510(k) Number: K063716

Juniper Medical, Inc. Juniper Cooling Device XTRA

CONFIDENTIAL

Tradiitonal 510(k) Page 16 of 187