MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE

K083500 · Dornier Medtech America, Inc. · GEX · Feb 12, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083500
• Device Name: MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

Device Story

Continuous-wave diode laser system emitting 940 nm radiation; used in clinical settings by physicians for soft tissue surgery. System features graphic display panel for monitoring operating parameters, application modes (Standard, Fibertom, LITT, LPS), time functions, and system status. Operates in contact or non-contact modes, with or without handpieces, and integrates with endoscopic equipment. Provides precise tissue interaction for cutting, ablation, and coagulation; benefits include minimally invasive surgical options for BPH and vascular conditions. User-controlled via interface; system calibrated during manufacturing and service.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics, design specifications, and compliance with voluntary safety standards (IEC 60601 series, IEC 60825-1) and FDA performance standards for light-emitting products.

Technological Characteristics

Continuous-wave diode laser; 940 nm wavelength; Class IV laser. Features graphic display panel for parameter control. Complies with IEC 60601-1 (safety), IEC 60601-1-6 (usability), IEC 60601-2-22 (surgical lasers), and IEC 60825-1 (laser safety). Operates in multiple modes: Standard, Fibertom, LITT, and LPS.

Indications for Use

Indicated for soft tissue cutting, vaporization, ablation, and coagulation in various surgical specialties; treatment of vascular lesions and unwanted hair; endovascular coagulation of greater saphenous vein for superficial vein reflux; treatment of reticular veins/branch varicosities; and treatment of BPH-related urinary outflow obstruction in men >50 years with prostate volumes 28-85 cc.

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

• Biolitec Ceralas Diode 100 W 980 nm Laser System (Model D 100) (K050824)

Submission Summary (Full Text)

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K 083500

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

| Submitter Name and<br>Address: | Dornier MedTech America, Inc.<br>1155 Roberts Blvd.<br>Kennesaw, GA 30144 | FEB 12 2009 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Theron Gober<br>Quality and Regulatory Manager | |
| Phone Number: | 770-514-6204 | |
| Fax Number: | 770-514-6288 | |
| Establishment<br>Registration Number: | 1037955 | |
| Date Prepared: | November 20, 2008 | |
| Device Trade Name(s): | Medilas D Family Lasers, including:<br>• Medilas D Litebeam<br>• Medilas D Litebeam +<br>• Medilas D Urobeam<br>• Medilas D Multibeam<br>• Medilas D FlexiPulse<br>• Medilas D MagnaPulse | |
| Device Common Name: | Diode Laser System | |
| Classification Name: | GEX - Laser Instrument, Surgical Powered | |
| Predicate Device(s): | Biolitec Ceralas Diode 100 W 980 nm Laser System (Model D<br>100) K050824 | |
| General Device<br>Description: | The Dornier Medilas D Family Lasers are continuous-wave<br>diode laser emitting laser radiation in the invisible range of<br>940 nm. Each is calibrated during the manufacturing process<br>and during service calls. The end-user does not calibrate<br>fibers for this system. The Medilas D Family Lasers<br>incorporate a graphic display panel, which shows laser<br>operating parameters, application modes, time functions,<br>system status and messages for the user. The Medilas D<br>Family Lasers feature several operating modes, including<br>Standard, Fibertom, LITT and LPS. The lasers can be used<br>in contact or non-contact open surgery with or without<br>handpieces. | |

Intended Use:

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The Dornier Medilas D Family Lasers, specifically the Medilas

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D Litebeam. Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology. Pulmonary Surgery, Gastroenterology, ENT, and Radiology,

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam. "Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes. and colonoscopies) in incision/excision vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins with branch varicosities.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

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Technological Characteristics:

Performance Data:

# Conclusion:

From a clinical perspective and comparing design specifications, the Dornier Medilas D Family Lasers and the predicate device are substantially equivalent. Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the proposed diode lasers and the predicate devices.

Dornier MedTech America, Inc. believes the minor differences of the Medilas D Family Lasers ant its predicates laser should not raise any concerns regarding the overall safety or effectiveness.

While no performance standards have been established for Diode lasers under Section 514 of the Federal Food. Drug. and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. See 21 C.F.R. §1040.10 and \$1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).

Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that the Medilas D Family Lasers and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dornier MedTech America, Inc. Theron Gober Quality and Regulatory Manager 1155 Roberts Blvd. Kennesaw, GA 30144

FEB 1 2 2009

Re: K083500

Trade/Device Name: Medilas D Family lasers 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: November 21, 2008 Received: November 25, 2008

Dear Mr. Gober:

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 probibitions against misbranding and a 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 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.

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Page 2 - Theron Gober

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

David Krone

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices · Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Proprietary to Dornier MedTech America, Inc.

### INDICATIONS FOR USE

510(k) Number (if known): K 083500

Device Name: Medilas D Family Lasers

#### Indications for Use

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +. Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, specialties: Pulmonary Surgery, Gastroenterology, ENT, and Radiology.

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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*David Krane*
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K083500 |
|---------------|---------|
|---------------|---------|

Dornier MedTech America, Inc.
Medilas D Family Lasers 510(k) Submission
2/12/2009Medilas D Family Lasers 510(K) Submission November 20, 2008