QUADROSTAR 532

K060457 · Asclepion Laser Technologies GmbH · GEX · Mar 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060457
• Device Name: QUADROSTAR 532
• 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 QuadroStar 532 Laser System is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.

Device Story

QuadroStar 532 is a frequency-doubled, diode-pumped solid-state (LBO) laser system. Device comprises a laser enclosure and an optic delivery system consisting of a fiber bundle and handpiece. Used by clinicians for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue. Operates by delivering laser energy to target tissue to achieve therapeutic effects. Clinical benefit derived from precise tissue interaction for lesion treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Frequency-doubled, diode-pumped solid-state (LBO) laser. Includes laser enclosure, fiber bundle, and handpiece. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.

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

• BeautyStar 532

Submission Summary (Full Text)

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

12040457

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStar 532 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: | January 31st, 2006 |
| Device Name: | QuadroStar 532 |
| Common Name: | QuadroStar 532 |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.481 |
| Equivalent Device: | BeautyStar 532 |
| Device Description: | The QuadroStar 532 Laser System is a frequency doubled<br>diode - pumped solid state laser (LBO) . It consists a laser<br>enclosure and optic delivery system (fiber bundle and<br>handpiece). |
| Intended Use: | The QuadroStar 532 is intended for vaporization and<br>photocoagulation of vascular and pigmented lesions in soft<br>tissue. |
| Comparison to: | The QuadroStar 532 Laser System is substantially equivalent<br>to the BeautyStar 532 Laser System, with the same<br>principles of operation, the same wavelength and<br>essentially the same power range as the predicate device for<br>the same indications for uses. |
| | 14.FEB.2006 0000100 |

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| Nonclinical Performance Data: | None |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance Data: | None |
| Conclusion: | The QuadroStar 532 Laser System is another<br>safe and effective device for vaporization and<br>photocoagulation of vascular and pigmented<br>lesions in soft tissue. |

Additional Information :

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2006

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

Re: K060457

Trade/Device Name: QuadroStar 532 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. Thieme:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Office 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 yours,

el. Mel.

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: QuadroStar 532 Laser System

Indications for Use:

The QuadroStar 532 Laser System is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.

メ 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)

elgmee

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

510(k) Number_ko60457

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