MEDILAS D FAMILY LASERS

K070536 · Dornier Medtech America, Inc. · GEX · May 21, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070536
• Device Name: MEDILAS D FAMILY LASERS
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 21, 2007
• 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, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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 medicine and surgery across multiple specialties. Device features graphic display panel for monitoring operating parameters, application modes (Standard, Fibertom, LITT, LPS), time functions, and system status. Operated by clinicians in contact or non-contact open surgery or with endoscopic equipment. Laser energy facilitates soft tissue management (cutting, vaporization, ablation, coagulation), vascular lesion treatment, hair removal, endovascular vein coagulation, and BPH symptom relief. System calibrated during manufacturing and service; end-user does not calibrate fibers. Output allows precise tissue interaction, enabling minimally invasive or open surgical procedures; benefits include reduced tissue trauma and effective management of urological and dermatological conditions.

Clinical Evidence

Bench testing only. Compliance with class IV performance standards for light-emitting products (21 C.F.R. §1040.10 and §1040.11) and voluntary standards including IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1.

Technological Characteristics

Continuous-wave diode laser; 940 nm wavelength. Class IV laser. Features graphic display panel for parameter monitoring. Operating modes: Standard, Fibertom, LITT, LPS. Compatible with endoscopic equipment and handpieces. Standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for soft tissue cutting, vaporization, ablation, and coagulation in various surgical specialties; treatment of vascular lesions; hair removal; endovascular coagulation of greater saphenous vein for superficial vein reflux; and treatment of urinary outflow obstruction due to BPH in men >50 years old 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

• Medilas D Compact (K982629, K003993)
• Medilas D fibertom (K982629, K003993, K021724)
• Medilas D SkinPulse (K000072, K020339, K021724)
• Medilas D SkinPulse S / D940 (K003993, K020339, K021724)

Submission Summary (Full Text)

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Proprietary to Dornier MedTech America, Inc.

070536

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 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas, Vice President<br>Regulatory/ Quality/ Clinical |
| Phone Number: | 770-514-6163 |
| Fax Number: | 770-514-6288 |
| Establishment<br>Registration Number: | 1037955 |
| Date Prepared: | February 23, 2007<br>MAY 21 2007 |
| 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 |
| Device Common Name: | Diode Laser System |
| Classification Name: | GEX - Laser Instrument, Surgical Powered |
| Predicate Device(s): | Medilas D Compact (K982629, K003993)<br>Medilas D fibertom (K982629, K003993, K021724)<br>Medilas D SkinPulse (K000072, K020339, K021724)<br>Medilas D SkinPulse S / D940 (K003993, K020339, K021724) |
| 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. |

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Intended Use:

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

The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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.

Technological From a clinical perspective and comparing design Characteristics: specifications, the Dornier Medilas D Family Lasers and the predicate devices 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 lasers should not raise any concerns regarding the overall safety or effectiveness.

Performance Data: 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

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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).

Conclusion:

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 devices 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dornier MedTech America, Inc. % Mr. Tim Thomas VP, Regulatory, Quality & Clinical 1155 Roberts Boulevard Kennesaw, Georgia 30144

MAY 2 1 2007

Re: K070536 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: February 23, 2007 Received: February 27, 2007

Dear Mr. Thomas:

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. Tim Thomas

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/industry/support/index.html.

Sincerely you

Mark N. Melker 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties:

- . Urology
- Plastic Surgerv .
- . General Surgery
- . Dermatology
- . Gynecology
- . Pulmonary Surgery
- . Gastroenterology
- ENT .
- Radiology .

The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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

| 510(k) Number | L603531 |
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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
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