QUADROSTAR 980

K060459 · Asclepion Laser Technologies GmbH · GEX · Mar 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060459
• Device Name: QUADROSTAR 980
• 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

Delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).

Device Story

Diode laser system; emits 980 nm wavelength laser beam; max power 25 W. Used for delivery of laser light to soft tissue in contact or non-contact modes; compatible with endoscopes, introducers, or catheters. Operated by physicians in surgical settings. Provides hemostasis, coagulation, incision, excision, vaporization, and ablation of soft tissue. Benefits include precise tissue interaction for various surgical specialties.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diode laser system; 980 nm wavelength; 25 W maximum power. Contact or non-contact delivery modes. Compatible with endoscopes, introducers, and catheters.

Indications for Use

Indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue (including cardiac tissue) in patients undergoing surgical procedures in otolaryngology, dental, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary, and cardiothoracic surgery.

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

• Ceralas D 980

Submission Summary (Full Text)

{0}------------------------------------------------

## MAR 2 () 2006

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

K060459

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStar 980 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 980 |
| Common Name: | QuadroStar 980 |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.481 |
| Equivalent Device: | Ceralas D 980 |
| Device Description: | The QuadroStar 980 is a diode laser system emitting a laser<br>beam at a wavelength of 980 nm with a maximum power<br>of 25 W. |
| Intended Use: | Delivery of laser light to soft tissue in the contact or non-<br>contact mode during surgical procedures, including via<br>endoscopes, introducers or catheters. The QuadroStar 980 is<br>generally indicated for incision, excision, vaporization,<br>ablation, hemostasis or coagulation of soft tissue in ear,<br>nose and throat and oral surgery (otolaryngology), dental<br>procedures, arthroscopy, gastroenterology, general surgery,<br>dermatology, plastic surgery, podiatry, urology, gynecology,<br>neurosurgery (peripheral nervous system), pulmonary<br>surgery cardiothoracic surgery. This QuadroStar 980 is |

Seite 1 von 2

{1}------------------------------------------------

specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue). The QuadroStar 980 Laser System is substantially equivalent Comparison to: to the Ceralas D 980 Laser System, with the same principles of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses. None Nonclinical Performance Data: Clinical Performance Data: None The QuadroStar 980 Laser System is another safe and Conclusion: effective device for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).

Additional Information :

None

14. FEB. 2016 Le vole (* 0 : 1 1 : 1 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 2 1 :

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060459

Trade/Device Name: QuadroStar 980 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: February 14, 2006 Received: February 22, 2006

Dear Mr. Thieme:

This letter corrects our substantially equivalent letter of March 20, 2006.

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 (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 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.

{3}------------------------------------------------

Page 2 - Mr. Reinhard Thieme

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 reguirements as set forth in the quality systems (OS) 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 continue 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.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

## 510(k) Number (if known): _KO6 DYS 9

Device Name: QuadroStar 980 Laser System

Indications for Use:

The QuadroStar 980 Laser System is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).

× 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)

> of Device Evaluation (ODE) Conci Division of General, Restorative, and Neurological Devices

510(k) Number_ko60459

14.FEB.2006 00 00112