LASER SYSTEM YELLOWSTAR

K013940 · Asclepion-Meditec AG · GEX · Feb 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013940
• Device Name: LASER SYSTEM YELLOWSTAR
• Applicant: Asclepion-Meditec AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The YellowStar is intended for treatment of vascular and pigmented lesions. The laser system YellowStar is restricted to sale to or use by licensed professionals in the United States.

Device Story

Laser System YellowStar consists of laser enclosure, fiber optic delivery system, and computer-controlled treatment parameter interface. Device used by licensed professionals in clinical settings for treatment of vascular and pigmented lesions. System delivers laser energy to target tissue; operator adjusts parameters via interface to manage treatment. Output affects tissue through laser-tissue interaction, intended to benefit patients by addressing vascular/pigmented skin conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Laser surgical instrument (21 CFR 878.4810). System includes laser enclosure, fiber optic delivery system, and computer-controlled treatment parameter interface.

Indications for Use

Indicated for the treatment of vascular and pigmented lesions in patients requiring laser therapy, to be used by licensed professionals.

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

• ConBio CuB-D10 (K932723, K942934)
• Metatech Vasculase (K883541, K903883)

Submission Summary (Full Text)

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## FEB 2 6 2002

## 510(k) SUMMARY ASCLEPION-MEDITEC AG Laser System YellowStar

KD13940

This 510(k) summary of safety and effectiveness for the ASCLEPION-MEDITEC AG Laser System YelowStar is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

ASCLEPION-MEDITEC AG Applicant:

- Prussingstrasse 41 Address: 07745 Jena, Germany
- Contact Person: Dr. Dirk Colditz Vice President Operations and International Regulatory Affairs
- [phone] Phone: Fax: [phone] [e-mail] e-mail:
- September 2001 Preparation date:

Device name: Laser System YellowStar

- YellowStar Common Name:
Classification

Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79

Con Bio CuB-D10 Legally marketed:

Description: The Laser System YellowStar consists of a laser enclosure, fiber optic delivery system and an computer controlled treatment parameter interface.

- The laser system YellowStar intended for treatment of vascular Intended Use: and pigmented lesions.
- The specifications of the YellowStar are the same as or Comparison to: very similar to those of legally marketed lasers such as the ConBio CuB-D10 (K932723, K942934) and Metatech Vasculase (K883541, K903883)

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- Performance data: None. The specifications and intended uses of the laser system YellowStar are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
- The YellowStar is substantially equivalent to legally marketed CONCLUSION: devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Asclepion-Meditec AG c/o William Kelley Asclepion-Meditec, Inc. 2961 West MacArthur Boulevard, #133 Santa Ana, California 92704

Re: K013940

Trade Name: Laser System YellowStar Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 1, 2001 Received: November 29, 2001

Dear Mr. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave to rearly 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 May 20, 1970, the characteriance 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, (Act) that do not require space, subject to the general controls provisions of the Act. The general thereofs, maintons 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 rr your device is elassinos (tional 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 or any I 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 - Mr. William Kelly

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

V. Mark A. Millbern

elia 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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## INDICATIONS FOR USE STATEMENT

K 613940 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Laser System YellowStar

Indication For USE Statement:

(Per 21 CFR 801.109)

The YellowStar is intended for treatment of vascular and pigmented lesions.

The laser system YellowStar is restricted to sale to or use by licensed professionals in the United States.

Mark H. Milliken

Restorative Devices 013940

510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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