LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)

K994116 · Aesculap-Meditec North America · GEX · Jun 1, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994116
• Device Name: LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
• Applicant: Aesculap-Meditec North America
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions. The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.

Device Story

The MeDioStar H is a pulsed diode laser system emitting coherent light at 808 nm. It is designed for the removal of unwanted body hair and vascular lesions. The device is available in two configurations: one without a cooling system (MeDioStar H) and one with an integrated skin cooling system (MeDioStar HC). It is intended for use by licensed professionals in clinical settings. The laser energy is applied to the skin to target hair follicles or vascular structures. The cooling system, when present, is used to manage skin temperature during treatment. The device is operated by a physician or trained professional to achieve cosmetic or therapeutic hair and lesion removal.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological and intended use similarities to predicate devices.

Technological Characteristics

Pulsed diode laser; 808 nm wavelength; coherent light emission. Available with or without integrated skin cooling system. Classified as a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for removal of unwanted body hair and vascular lesions in patients treated 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

• Coherent / Palomar LightSheer (K982940)
• LASERSCOPE - Lyra (K990903)
• Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER (K984601)

Submission Summary (Full Text)

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JUN - 1 2000

## K994116

## 510(k) SUMMARY AESCULAP-MEDITEC GMBH LASER SYSTEM MeDioStar H WITH AND WITHOUT COOLING SYSTEM FOR SKIN

This 510(k) summary of safety and effectiveness for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H with and without skin cooling system 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.

Applicant: AESCULAP-MEDITEC GMBH

- Address: Prussingstrasse 41 07739 Jena, Germany
Contact Person: Dr. Dirk Colditz Quality Management Representative

- [phone] Phone: Fax: [phone] e-mail: [e-mail]
Preparation date: March 1999

Device name: Laser System MeDioStar H (with and without skin cooling system)

- Common Name: MeDioStar H ( without skin cooling system ) MeDioStar HC ( with skin cooling system )
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
- Coherent / Palomar LightSheer ( K982940 ) Legally marketed: LASERSCOPE - Lyra ( K990903 ) Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER ( K984601 )
- Description: The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.
- Intended Use: The laser system MeDioStar H is intended to remove unwanted body hair and vascular lesions.
- Comparison to: The specifications of the MeDioStar are the same as or

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very similar to those of legally marketed lasers such as the Conerent / Palomar - LightSheer ( K982940 ), the LASERSCOPE - Lyra ( K990903 ) and the Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER ( K984601 )

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2000

Mr. William Kelley Aesculap-Meditec North American 2525 McGaw Avenue Irvine, California 92623

K994116 Re:

R 77+110
Trade Name: Laser System MeDioStar H With and Without Skin Cooling System Laser System MeDioStar With and Without Skin Cooling System

Regulatory Class: II Product Code: GEX Dated: February 21, 2000 Received: March 7, 2000

Dear Mr. Kelley:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomer be device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to ase suted in the enactment date of the Medical Device Amendments, or to devices that May 20, 1970, the cities accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Fel (110). "The general controls provisions of the Act include requirements for provisions of and From 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 ( remailed in provide), with device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the I urrent Good Manufacturing Practice requirement, as set forth in the Quality 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 and assumptions. Failure to comply with the GMP regulation may result in regulatory Such assumptions: "Farma vos vour of Federal Register. Please note: this response to your premarket notification submission does r cochar regions. Tour 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 10(k) This letter will anow you to begin maineting , but antial equivalence of your device to a premarket nothleation. The PDA miding of substance of the results 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 If you desire specific advice 10- 75-diagnostic devices), please contact the Office of and additionally 607.10 for in 1150 and the promotions on the promotion and Compliance at [phone]. Atuationally, 1993 of Compliance at [phone]. advertising of your device, produs titled, "Misbranding by reference to premarket Also, prease flote the regulation entition, "Information on your responsibilities under the nothication (21 CPX 607.97). Other general Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dana R. Kirchner

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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K994116

Device Name: _Laser System MeDioStar H with and without skin cooling system

Indication For USE Statement:

The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

Dena R. bochner.

Division Sign-Off) Division of General Restorative Devices 510(k) Number