VARI-LASE ENDOVENOUS LASER CONSOLE

K093502 · Vascular Solutions, Inc. · GEX · Jan 7, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093502
• Device Name: VARI-LASE ENDOVENOUS LASER CONSOLE
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vari-Lase Endovenous Laser Console is indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Story

Vari-Lase Endovenous Laser Console is a software-controlled diode laser system. It delivers 810 nm wavelength laser energy with a maximum output of 15 W. Used by clinicians in a medical setting to treat venous insufficiency. The device provides thermal energy to the vein, facilitating closure. It functions as a surgical laser instrument. The system is designed for endovenous procedures to address varicose veins and superficial reflux.

Clinical Evidence

Bench testing only.

Technological Characteristics

Diode laser; 810 nm wavelength; 15 W maximum output; software-controlled; Class II laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for treatment of varicose veins, varicosities associated with superficial reflux of the Great Saphenous Vein, and incompetence/reflux of superficial veins in the lower extremity.

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

• Vari-Lase Endovenous Laser Console (K062822)
• Diomed Delta 15 Laser Console (K051996)

Submission Summary (Full Text)

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

Vascular Solutions, Inc.

K 093502

Special 510(k) Premarket Notification Vari-Lase Endovenous Laser Console

#### 2 510(k) Summary

| Date Prepared: | December 23, 2009 | JAN - 7 2010 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufactured for: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, MN 55369<br>Establishment Registration #2134812 | |
| Contact Person: | Jennifer Ruether<br>Regulatory Affairs Associate<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |

### General Information:

| Trade Name: | Vari-Lase Endovenous Laser Console |
|----------------------|---------------------------------------------------------------------------------------|
| Common Name: | Laser Console |
| Classification Name: | Laser instrument, surgical, powered<br>(21 CFR 878.4810; Product code GEX) |
| Predicate Devices: | K062822, Vari-Lase Endovenous Laser Console<br>K051996, Diomed Delta 15 Laser Console |

#### Device Description:

The Vari-Lase Endovenous Laser Console is a software controlled diode laser that provides an output wavelength of 810 nm and operates at a maximum output of 15 W.

# Intended Use/Indications for Use

The Vari-Lase Endovenous Laser Console is indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

## Substantial Equivalence

The Vari-Lase Endovenous Laser Console (15 W) substantially equivalent to the currently marketed predicate device, based on comparisons of the device classifications, technological characteristics, and the Indications for Use.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The symbol on the right is a stylized representation of a human figure embracing an eagle, which is a common emblem associated with the HHS.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vascular Solutions, Inc. · % Ms. Jennifer Ruether Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

JAN - 7 2010

Re: K093502

Trade/Device Name: Vari-Lase Endovenous Laser Console 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 16, 2009

Received: December 17, 2009

Dear Ms. Ruether:

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 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

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

Page 2 - Ms. Ms. Jennifer Ruether

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Vascular Solutions, Inc.

Special 510(k) Premarket Notification Vari-Lase Endovenous Laser Console

# Indications for Use

510(k) Number (if known):

Device Name: Vari-Lase® Endovenous Laser Console

Indications for Use:

The Vari-Lase procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1
(Posted November 13, 2003)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number. K093502