JUNIPER COOLING DEVICE

K060407 · Juniper Medical Technology, Inc. · GEX · May 31, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060407
• Device Name: JUNIPER COOLING DEVICE
• Applicant: Juniper Medical Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Juniper Cooling Device 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.

Device Story

Thermoelectric cooling device; applies controlled cooling to skin treatment site. Used during laser and dermatological procedures to minimize pain and thermal injury; acts as local anesthetic for minor discomfort. Operated by healthcare professionals in clinical settings. Device provides cooling output to treatment area; assists in patient comfort and safety during procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Thermoelectric cooling device. Standalone unit. No software or algorithm described.

Indications for Use

Indicated for patients undergoing laser or dermatological procedures requiring skin cooling to minimize pain and thermal injury, or as a local anesthetic for procedures inducing minor local discomfort.

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

• Paradgim-Trex LLC DermaChiller 4 (K014253)
• Zimmer Elektromedizin GmbH Cryo 5 (K040727)
• Cutera Optional Pulse Light Hand Piece (K050047)
• Opusmed F1 Diode Laser System (K030235)

Submission Summary (Full Text)

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## 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 | MAY 3 1 2006 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 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 | GEX | |
| PREDICATE<br>DEVICE: | The Juniper Cooling Device is substantially equivalent to the<br>Paradgim-Trex LLC DermaChiller 4 (K014253), to the Zimmer<br>Elektromedizin GmbH Cryo 5 (K040727), to the Cutera<br>Optional Pulse Light Hand Picce (K050047), and to the<br>Opusmed F1 Diode Laser System (K030235). | |

## SUBSTANTIALLY EQUIVALENT TO:

The Juniper Cooling Device is substantially equivalent to the Paradgim-Trex LLC DermaChiller 4 (K014253), to the Zimmer Elektromedizin GmbH Cryo 5 (K040727), to the Cutera Optional Pulse Light Hand Piece (K050047), and to the Opusmed F1 Diode Laser System (K030235).

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Juniper Cooling Device a thermoelectric cooling device that applies controlled cooling to a treatment site.

#### INDICATION FOR USE:

The Juniper Cooling Device 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.

Juniper Medical, Inc.

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# Response to Formal Request for Additional Information

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#### TECHNICAL CHARACTERISTICS:

The Juniper Cooling Device is a thermoelectric cooling device.

#### PERFORMANCE DATA:

Testing confirms that the Juniper Cooling Device can be used in an equivalent manner to the predicate devices. 【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【

### BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The indications for use for the Juniper Cooling Device are the same as predicate devices cited in this application. A technological comparison and bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices.

Juniper Medical, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 3 1 2006

Juniper Medical, Inc. % Ms. Rosemary Harry Acting VP of Clinical and Regulatory Affairs 7139 Koll Center Parkway, Suite 300 Pleasanton, California 94566

Re: K060407

Trade/Device Name: Juniper Cooling Device 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 Dated: May 12, 2006 Received: May 15, 2006

#### Dear Ms. Harry:

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

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## Page 2 - Ms. Rosemary Harry

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. This letter will allow you to begin marketing your device as described in your Section 510/kk 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Mark N. Melkersd 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.

INDICATIONS FOR USE STATEMENT

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K060407

Device Name: Juniper Cooling Device

Indications for Use:

The Juniper Cooling Device 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.

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)

.m.ll

(Division Sign-O Division of General, Restorative, and Neurological Devices

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510(k) Number k060407