MULTISTAR

K060455 · Asclepion Laser Technologies GmbH · GEX · Mar 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060455
• Device Name: MULTISTAR
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MultiStar is intended for coagulation, ablation. vaporization, incision, excision, cutting of soft tissue in plastic surgery, general surgery, oral surgery, ENT, gynecology and dermatology.

Device Story

MultiStar Laser System is a CO2 gas laser emitting coherent light at 10600 nm wavelength with maximum power of 30 Watts. Device used for soft tissue surgical procedures including coagulation, ablation, vaporization, incision, and excision. Operated by clinicians in surgical settings (plastic, general, oral, ENT, gynecology, dermatology). Laser energy interacts with soft tissue to achieve desired surgical effect. Device provides controlled thermal energy for tissue management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

CO2 gas laser; 10600 nm wavelength; 30 Watt maximum power; Class II device (21 CFR 878.4810).

Indications for Use

Indicated for coagulation, ablation, vaporization, incision, excision, and cutting of soft tissue in plastic surgery, general surgery, oral surgery, ENT, gynecology, and dermatology.

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

• Multipulse Laser System

Submission Summary (Full Text)

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## 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar miXT Laser System

KOLOYST

This 510(k) summary of safety and effectiveness for the Asclepion Laser This of othy Juminary of Sales) 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:<br>Fax:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| Preparation Date: | January 31st, 2006 |
| Device Name: | MultiStar |
| Common Name: | MultiStar |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.481 |
| Equivalent Device: | Multipulse |
| Device Description: | The MultiStar Laser System is a CO2 - Gas Laser. It emits<br>a beam of coherent light at the wavelength of 10600 nm<br>with a maximum power of 30 Watt |
| Intended Use: | The MultiStar is intended for coagulation, ablation.<br>vaporization, incision, excision, cutting of soft tissue in<br>plastic surgery, general surgery, oral surgery, ENT,<br>gynecology and dermatology. |
| Comparison to: | The MultiStar Laser System is substantially equivalent to<br>the Multipulse Laser System, with the same principles of<br>operation, the same wavelength and essentially the same<br>power range as the predicate device for the same<br>indications for uses. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The MultiStar Laser System is another safe<br>and effective device for coagulation, ablation,<br>vaporization, incision, excision, cutting of soft<br>tissue in plastic surgery, general surgery,<br>oral surgery, ENT, gynecology and<br>dermatology. |

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Additional Information :

None

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2006

Asclepion Laser Technologies GmbH c/o Mr. Reinhard Thieme Goeschwitzerstrasse 51-52 Jenna, Germany 07745

Re: K060455

Trade/Device Name: MultiStar 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: February 14, 2006 Received: February 22, 2006

Dear Mr. Thicme:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined 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 encreations 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, 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 r ou may, atere, marros 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 rryour device 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

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Page 2 -- Mr. Reinhard Thieme

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) This letter will and in yourse organ finding of substantial equivalence of your device to a legally premarket noticated 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 If you attire 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/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

dl.gmee

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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): צור צ

Device Name: MultiStar Laser System

Indications for Use:

The MultiStar Laser System is intended for the coagulation, ablation, THE Mantistar Laser of excision, cutting of soft tissue in plastic surgery, general surgery, oral surgery, ENT, gynecology and dermatology.

× 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)

E.gndee

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

510(k) Number_K06c452

14.FEB.2006 0000117