CRYOFLOW 700, CRYOFLOW 1000

K052310 · Uniphy Elektromedizin GmbH & Co. KG · GEX · Mar 15, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052310
• Device Name: CRYOFLOW 700, CRYOFLOW 1000
• Applicant: Uniphy Elektromedizin GmbH & Co. KG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cryoflow 700 and Cryoflow 1000 are intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Story

Cryoflow 700 and 1000 are skin refrigerant devices; refrigeration unit generates cold air; cold air delivered to skin via air hose; used in clinical settings during laser and dermatological procedures; operated by healthcare professionals; provides localized cooling to minimize pain and thermal injury; serves as temporary topical anesthetic for injections; benefits patient by reducing discomfort and potential thermal damage during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Refrigeration unit producing cold air; air hose delivery system; standalone device; no specific materials or software algorithms described.

Indications for Use

Indicated for patients undergoing laser or dermatological treatments to minimize pain and thermal injury, and for temporary topical anesthetic relief during 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

• Cryo 5 (Zimmer) (K040727)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for a company called "uniphy Elektromedizin". The logo consists of a stylized wave-like graphic above the word "uniphy", with the word "Elektromedizin" appearing below. The text is in a simple, sans-serif font and the overall design is clean and modern.

MAR 1 5 2006

## Abbreviated 510(k) submission for cryflow 700 and cryflow 1000.

## 510(k) Summary

KOS2310

| Date prepared: | August 19, 2005 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Uniphy Elektromedizin GmbH & Co. KG<br>19B Neuendorferstraße<br>16761 Hennigsdorf<br>Germany<br>Contact Name: Reiner Tostmann, Doc-Eng<br>Phone Number: 11-49-3302-50440<br>FAX Number: 11-49-3302-504499<br>E-mail: [e-mail] |
| Device trade name: | Cryoflow 700, Cryflow 1000 |
| Common name: | Skin Refrigerant |
| Classification name: | Class 2 (21CFR 878.4810) 78 GEX<br>Laser surgery instrument for use in general and plastic<br>surgery and dermatology. |
| Description of device: | The Cryoflow 700 and Cryoflow 1000 consists of a refrigeration unit<br>that creates cold air. The cold air is blown onto the skin<br>using an air hose. |
| Performance Standards: | None established (as a medical device) under section 514. |
| Intended use of the device: | The Cryoflow 700 and Cryoflow 1000 are intended to minimize<br>pain and thermal injury during laser and dermatological<br>treatments and for temporary topical anesthetic relief for<br>injections. |

Substantial equivalence claim to the following legally marketed device: Cryo 5 (Zimmer). K040727

## Summary of substantial equivalence:

The Uniphy Cryoflow 700 and Cryflow 1000 are substantially equivalent to the compared device on the basis of similarities in operating principles, intended use and functional performance.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Gymnauniphy N.V. c/o Nico Beun Uniphy Elektromedizin GmbH & Co. KG Pasweg 6A Belzen 3740 Belgium

Re: K052310 Trade/Device Name: Cryoflow 700, Cryflow 1000 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: August 22, 2005 Received: August 24, 2005

Dear Nico Beun:

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 cither 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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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 vours.

emall

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/1 description: The image shows the logo for Uniphy Elektromedizin. The logo consists of a stylized wave-like graphic to the left of the word "uniphy" in a sans-serif font. Below "uniphy" is the word "Elektromedizin", also in a sans-serif font, but slightly smaller than "uniphy".

Uniphy Elektromedizin GmbH & Co. KG Neuendorfstraße 19 b D-16761 Hennigsdorf Germany

## Indications for Use

510(k) Number (if known): K052310

Device Name: Cryoflow 700, Cryoflow 1000

- Indications for Use:
.

- The Cryoflow 700 and Cryoflow 1000 are intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

| 510(k) Number | K052310 |
|---------------|---------|
|---------------|---------|

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(Posted November 13, 2003)