MEDIOSTAR XT

K050900 · Asclepion Laser Technologies GmbH · GEX · May 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050900
• Device Name: MEDIOSTAR XT
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.

Device Story

MeDioStar XT is a pulsed diode laser system (808µm wavelength) designed for dermatological applications. The system comprises a laser enclosure and an optic delivery system (fiber bundle and handpiece). It is operated by healthcare professionals in a clinical setting. The device delivers laser energy to target tissues to achieve hair removal or treat vascular lesions. The system is substantially equivalent to the MeDioStar H Laser System, utilizing the same principles of operation, wavelength, and power range. Clinical benefit is derived from the thermal effects of the laser on the targeted hair follicles or vascular structures.

Clinical Evidence

No clinical performance data provided. Bench testing only.

Technological Characteristics

Pulsed diode laser; 808µm wavelength; consists of laser enclosure, fiber bundle, and handpiece. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for the removal of unwanted body hair and the treatment of vascular lesions in patients requiring laser-based dermatological procedures.

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

• MeDioStar H Laser System

Submission Summary (Full Text)

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MAY 1 6 2005

Image /page/0/Picture/1 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a bold, sans-serif font, with a cluster of black dots of varying sizes above and to the right of the word. Below "Asclepion" is the phrase "Laser Technologies" in a smaller font.

Asclepion Laser Technologies GmbH • Göschwitzer Str. 51-52 • D-07745 Jena

## 510(k) SUMMARY

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## ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar XT Laser System

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MeDioStar XT Laser System is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH<br>Goeschwitzer Str. 51-52<br>07745 Jena, Germany |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Reinhard Thieme<br>Quality Assurance and<br>International Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |
| Preparation Date: | March 23, 2005 |
| Device Name: | MeDioStar XT Laser System |
| Common Name: | MeDioStar XT |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.481 |
| Equivalent Device: | MeDioStar H Laser Sytsem<br>(with and without skin cooling system) |
| Device Description: | MeDioStar XT Laser System is a pulsed diode laser with a<br>wavelength of 808µm. It consists a laser enclosure and optic<br>delivery system (fiber bundle and handpiece). |

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| Intended Use: | The MeDioStar XT Laser System is intended to remove<br>unwanted body hair and vascular lesions. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to: | The MeDioStar XT Laser System is substantially equivalent to<br>the MeDioStar H Laser System (with and without skin cooling),<br>with the same principles of operation, the same wavelength and<br>essentially the same power range as the predicate device for the<br>same indications for uses. |
| Nonclinical<br>Performance Data: | None |
| Clinical<br>Performance Data: | None |
| Conclusion: | The MeDioStar XT Laser System is another safe and effective<br>device for the removal of unwanted body hair and the treatment<br>of vascular lesions. |
| Additional Information: | None |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2005

Mr. Reinhard Thieme Quality Assurance and International Regulatory Affairs Asclepion Laser Technologies GmbH Goeschwitzerstrasse 51-52 Jena, Germany 07745

Re: K050900

Trade/Device Name: MeDioStar XT Laser System 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: April 26, 2005 Received: April 28, 2005

Dear Mr. Thieme:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of 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, de nees mat have been 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 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 or any I catala 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 Of N 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. Reinhard Thieme

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 manceing your ntial equivalence of your device to a legally premarket notification. "The PDF Intering of our 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 If you desire specific advice for your 2001 276-0115 . Also, please note the regulation entitled, Colliact the Office of Comphalled at (217) = 16 = 16 = 18 = 1 = 1 = 1 = 0 may obtain Missuranting of Icrerchee to premantonibilities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Consults. 1/10:2018. 1/2 1/2017 1/2017 1/10/11/10 1/1

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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): 长6 So 960

Device Name: MeDioStar XT Laser System

Indications for Use:

The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) :

Concurrence of CDRH, Office of Device Evaluation (ODE)

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