TECHNOSANAT KRYO TSK 2005

K992536 · Technosanat Innovative Medizintechnik GmbH · GEX · Oct 8, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992536
• Device Name: TECHNOSANAT KRYO TSK 2005
• Applicant: Technosanat Innovative Medizintechnik GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TECHNOSANT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for: 1. The reduction of pain associated with laser treatment, 2. Less discomfort, 3. Cooling of the skin just before the laser impulse treatment.

Device Story

Skin-cooling device used as accessory to surgical lasers; supports cutaneous laser procedures. Device comprises control unit and treatment applicator connected via hoses. Cooling generated via Peltier element; transferred to patient skin via metallic contact tip. Temperature sensor in applicator monitors surface temperature; displayed on controller. Used in clinical settings (dermatology/plastic surgery) by trained personnel. Provides topical cooling to skin surface to reduce pain and thermal injury risk during laser therapy.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence claimed based on similarity of specifications and intended use to predicate devices.

Technological Characteristics

Peltier-based cooling system; metallic finger transfer medium for skin contact. Includes temperature sensor and controller display. Standalone device connected to laser system via hose lines.

Indications for Use

Indicated for patients undergoing cutaneous laser treatment to reduce pain, minimize discomfort, and provide skin cooling prior to laser impulse delivery.

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

• Palomar E2000 System
• Laserscope Coolspot
• Optimed Dermacool
• Candela Dynamic cooling device

Submission Summary (Full Text)

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TECHNOSANAT Innovative Medizintechnik Joerg Trempert, Gewerbepark Keplerstrasse 10 -12, 07549 Gera, Germany

# 510(k) SUMMARY

K992536

# TECHNOSANAT KRYO TSK 2005

This 510(k) summary of safety and effectiveness for the TECHNOSANAT Innovative Medizintechnik TECHNOSANAT KRYO TSK 2005 is submitted in accordance with the requirements of 21 CFR Part 807 Subpart E § 807.92 and follows the DSMA Office of Health and Industry Programs Guidance: Premarket Notification 510(k) - Regulatory Requirements for Medical Devices (HHS Publication FDA 95-4158, August 1995) concerning the requirements for a 510(k) Summary and Statement.

| Applicant: | TECHNOSANAT<br>Innovative Medizintechnik |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Gewerbepark Keplerstrasse 10 -12<br>07549 Gera, Germany |
| Contact Person: | Joerg Trempert<br>President |
| Phone:<br>Fax:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| Preparation date: | July 10, 1999 |
| Device name: | Cooling device TECHNOSANAT KRYO TSK 2005 |
| Common Name: | TECHNOSANAT KRYO TSK 2005 |
| Classification<br>Name: | Cooling device as accasessory to a Laser surgical instrument for use<br>in general and plastic surgery and in dermatology (21 CFR 878.4810)<br>Product code: GEX - Laser instrument, surgical, powered<br>Panel: SU |
| Legally marketed<br>devices (SE): | The Technosanat Kryo TSK 2005 is substantially equivalent to the Palomar<br>E2000 System, Laserscope Coolspot, Optimed Dermacool an the Candela<br>Dynamic cooling device. The operating principle of these devices is topical<br>application of a low-temperature material to the surface of the skin in order to<br>reduce its temperature. |
| | See also Table of Comparison. |
| Device Description: | TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed for<br>support of laser treatment. The device consists of a control device and the<br>treatment applicator which are connected via hose lines. Cold is generated in<br>the applicator by means of Peltierelement, and directed to the patient via a<br>metallic finger transfer medium. A piece of cooled metal comes in contact with<br>skin and performs skin cooling. The treatment temperature is recorded by<br>means of one temperature sensor in the applicator and is then displayed on<br>the device's temporatur controllar |

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| Intended Use: | TECHNOSANT KRYO TSK 2005 is intended for use in conjunction with a<br>laser to provide surface cooling during cutaneous laser treatment and is a<br>cooling device indicated for:<br>1. The reduction of pain associated with laser treatment,<br>2. Less discomfort,<br>3. Cooling of the skin just before the laser impulse treatment. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to: | The intended use of the TECHNOSANT KRYO TSK 2005 is substantially<br>equivalent to predicate devices in that they are intended to reduce pain and<br>minimize thermal injury to skin structures during laser therapy. |
| Performance data: | None. The specifications and intended uses of TECHNOSANT KRYO TSK<br>2005 are the same or very similar to those of claimed predicate devices.<br>Because of this, performance data were not required. |
| CONCLUSION: | The risks and benefits for the TECHNOSANT KRYO TSK 2005 are<br>comparable to the predicate devices when used for similar clinical applications<br>and therefore is the TECHNOSANT KRYO TSK 2005 substantially equivalent<br>to legally marketed devices. |

:

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

Technosant Innovative Medizintechnik, GMBH C/o Mr. William Kelley Aesculap-Meditec North America 2525 McGaw Avenue Irvine, California 92623

Re: K992536

> Trade Name: TECHNOSANAT KRYO TSK 2005 Regulatory Class: II Product Code: GEX Dated: July 7, 1999 Received: July 29, 1999

Dear Mr. Kelley:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. William Kelley

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K992536

#### Device Name: TECHNOSANAT KRYO TSK 2005

Indications For Use:

TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:

1. The reduction of pain associated with laser treatment,

2. Less discomfort.

3. Cooling of the skin just before laser impulse treatment.

Refer to the user manual for the laser to which the device is attached for cleared indications for use.

(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 Devices K992536
510(k) Number