DORNIER MEDILAS D LITEBEAM+ 1470

K110364 · Dornier Medtech America, Inc. · GEX · Dec 7, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110364
• Device Name: DORNIER MEDILAS D LITEBEAM+ 1470
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dornier Medilas D LiteBeam + 1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is intended for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.

Device Story

Continuous-wave diode laser system emitting 1470 nm invisible radiation; delivers laser light to soft tissue in non-contact mode. Features graphic display panel for monitoring operating parameters, application modes, time functions, and system status. Includes multiple operating modes: Standard, Fibertom, and LPS. Used by clinicians in surgical settings for general surgery and venous procedures. Provides thermal energy to target tissue; output parameters controlled by user via interface. Benefits include minimally invasive treatment of venous reflux.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and compliance with voluntary standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1) and Class IV performance standards.

Technological Characteristics

Diode laser, 1470 nm wavelength, continuous-wave output. Class IV laser. Complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1. Includes graphic display for parameter control. Non-contact delivery mode.

Indications for Use

Indicated for patients requiring soft tissue surgery and treatment of saphenous vein reflux associated with varicose veins and varicosities.

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

• Biolitic 15W Ceralas Diode 1470nm Laser (K073063)

Submission Summary (Full Text)

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Proprietary to Dornier MedTech America, Inc.

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.

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| Submitter Name and<br>Address: | Dornier MedTech America, Inc.<br>1155 Roberts Blvd.<br>Kennesaw, GA 30144 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Hoffer<br>Vice President, Quality, Regulatory, Clinical |
| Phone Number: | 770-514-6163 |
| Fax Number: | 770-514-6291 |
| Establishment<br>Registration Number: | 1037955 |
| Date Prepared: | September 27, 2011 |
| Device Trade Name(s): | Medilas D LiteBeam+ 1470 |
| Device Common Name: | Diode Laser System |
| Regulation Number: | 21 CFR 878.4810 |
| Regulation Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Regulatory Class: | Class II |
| Product Code: | GEX |
| Predicate Device(s): | The Dornier Medilas D LiteBeam+ 1470 is substantially<br>equivalent to the Biolitic 15W Ceralas Diode 1470nm Laser<br>(K073063). |
| | |
| General Device<br>Description: | The Dornier Medilas D Lite Beam + 1470 Laser is a<br>continuous-wave diode laser emitting laser radiation in the<br>invisible range of 1470 nm. The Medilas D LiteBeam+ 1470<br>incorporates 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>LiteBeam+ 1470 features several operating modes, including |

Standard, Fibertom and LPS.

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The Dornier Medilas D LiteBeam 1470 is a diode laser that is Intended Use: intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is intended for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

- Technological From a clinical perspective and comparing design Characteristics: specifications, Dornier Medilas D Lite Beam + 1470 Laser and the predicate device is 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 laser and the predicate device.
Dornier MedTech America, Inc. believes the minor differences of the Dornier Medilas D Lite Beam + 1470 Laser and its predicate laser 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 LiteBeam+ 1470 is 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 laser also complies 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 Conclusion: performance of the devices. Dornier MedTech America, Inc. believes that the Dornier Medilas D Lite Beam + 1470 Laser 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC - 7 2011

Dornier MedTech America, Inc. % Mr. John Hoffer Vice President, Quality, Regulatory, Clinical 1156 Roberts Boulevard Kennesaw, Georgia 30144

Re: K110364

Trade/Device Name: Dornier Medilas D LiteBeam + 1470 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 02, 2011

Received: December 02, 2011

Dear Mr. Hoffer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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Page 2 – Mr. John Hoffer

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative 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):

Device Name: Dornier Medilas D LiteBeam + 1470

Indications for Use:

The Dornier Medilas D LiteBeam + 1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is intended for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.

Prescription Use X (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)

N.I.I.R.P. Order for mkm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number