DERMACHILLER 4

K014253 · Paradigm Trex, LLC · GEX · Mar 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014253
• Device Name: DERMACHILLER 4
• Applicant: Paradigm Trex, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DermaChiller 4 is intended as a skin-cooling device to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Story

DermaChiller 4 is a skin-cooling device; utilizes refrigerant fluid delivered via electronically operated solenoid valve; sprays refrigerant onto sapphire window; cooled window applied to skin surface. Used in clinical settings by healthcare professionals during laser/dermatological treatments or procedures causing minor local discomfort. Device provides localized cooling to minimize pain and thermal injury; acts as temporary topical anesthetic. Output is physical cooling of skin via contact with sapphire window; assists clinicians in managing patient comfort during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

System consists of refrigerant fluid source, electronically operated solenoid delivery valve, and sapphire contact window. Operates via spray-cooling mechanism. Device is a Class II medical device (21 CFR 878.4810).

Indications for Use

Indicated for patients undergoing laser or dermatological procedures requiring pain/thermal injury mitigation, or requiring temporary topical anesthetic relief for injections.

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

• CoolSpot (K984110)
• Dynamic Cooling Device (K001589)
• DermaCool (K990417)

Submission Summary (Full Text)

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## 3. 510(k) SUMMARY

014253

MAR 2 6 2002

12/20/2001 Date Prepared:

Paradigm-Trex, LLC Submitter: 10455 Pacific Center Court San Diego, CA 92121-4339 Contact Person: Nikolai Tankovich, Ph.D. MD Phone: [phone] FAX: [phone]

Device Trade Name: DermaChiller 4

Skin refrigerant Common Name:

Class II (21 CFR 878.4810) Classification: Laser surgical instrument for use in general and plastic surgery and in dermatology.

Product Code: GEX

### Performance Standards:

None established (as a medical device) under Section 514.

#### Description of Device:

The DermaChiller consists of a source of a refrigerant fluid controlled by an electronically operated solenoid delivery valve. The refrigerant fluid is sprayed in a controlled fashion onto a sapphire window, which is cooled and applied to skin.

#### Intended Use of the Device:

The DermaChiller 4 is intended as a skin-cooling device used 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.

#### Substantial Equivalence Claim to:

- 1. CoolSpot 510(k) Number K984110
- 2. Dynamic Cooling Device 510(k) Number K001589
- 3. DermaCool-510(k) Number K990417

6

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2002

Paradigm Trex, LLC Nikolai Tankovich, Ph.D., M.D. Chief Executive Officer 10455 Pacific Center Court San Diego, California 92121-4339

Re: K014253

Trade Name: DermaChiller 4 Regulation Number: 878.4810 Regulation Name: U or reloved instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: December 20, 2001 Received: December 26, 2001

Dear Dr. Tankovich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, eond 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 - Nikolai Tankovich, Ph.D., M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mansting your valence of your device to a legally premarket notification. The PDA mixing of basification 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 and If you desire specific advice for your devices disgnostic devices), please contact the Office of additionally 21 CFK Part 807.10 for in Viato Classions on the promotion and advertising of Compliance at [phone]. Tidatonally) 18 - 4639. Also, please note the your device, prease odmate and extereference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsibility of the mer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

G Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 2. INDICATIONS FOR USE STATEMENT

K014253 510(k) Number:

DermaChiller 4 Device Name:

> Indications for Use: The DermaChiller 4 is intended as a skin-cooling device to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

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Concurrence of CDHR, office of Device Evaluation (ODE)

Prescription Use

✓

OR

Over-The-Counter Use_

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K014253