VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500

K062822 · Vascular Solutions, Inc. · GEX · Nov 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062822
• Device Name: VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Vari-Lase Endovenous Laser Console is a software-controlled diode laser system. It delivers 810 nm wavelength laser energy to treat varicose veins and superficial venous reflux in the lower extremity. Operated by clinicians in a surgical or clinical setting, the device provides therapeutic laser energy to induce vein closure. The system is substantially equivalent to previously cleared laser consoles, utilizing established laser surgical technology for endovenous procedures. No clinical data was generated for this specific submission; safety is supported by compliance with established electrical and laser safety standards.

Clinical Evidence

No clinical evaluations were conducted for this device. Bench testing was limited to verification of compliance with electrical safety and electromagnetic compatibility standards (EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, and EN 60601-2-22).

Technological Characteristics

Diode laser system; 810 nm output wavelength; software-controlled. Complies with EN 60601-1 (General Safety), EN 60601-1-1 (Medical Electrical Systems), EN 60601-1-2 (EMC), EN 60601-1-4 (Programmable Electrical Medical Systems), and EN 60601-2-22 (Diagnostic/Therapeutic Laser Equipment).

Indications for Use

Indicated for treatment of varicose veins and 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

• Vascular Solutions Vari-Lase™ Laser Console (K033237)
• Diomed, Inc. Diomed 15 Plus Laser System (K023543 and K041957)

Submission Summary (Full Text)

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## 510(k) Summary

# 510(k) Number: K 062822

#### Date Prepared

September 15, 2006

NOV 2 1 2006

## Submitter Information

Submitter's Name/ Address:

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

Contact Person:

Patrice Stromberg Sr. Regulatory Affairs Associate [e-mail] [phone] (phone) [phone] (fax)

#### Device Information

Trade Name: Common Name: Classification Name:

Product Code: Regulation:

Predicate Devices

Vari-Lase™ Endovenous Laser Console and Laser Instrument Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology GEX Class II, 21 CFR 878-4810

Vascular Solutions Vari-Lase™ Laser Console (K033237) Diomed, Inc. Diomed 15 Plus Laser System (K023543 and K041957)

#### Device Description

The Vari-Lase Console is a software controlled diode laser that provides an output wavelength of 810 nm.

#### Intended Use/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.

#### Summary of Non-Clinical Testing

Additional testing was not conducted for the upgrades to this device. Testing was previously conducted to verify the laser console is in compliance with the following clectrical safety standards. No circuitry was changed that would affect the electrical safety of the Vari-Lase Console.

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- . EN 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Safety
- EN 60601-1-1: Medical Electrical Equipment Part 1-1: General . Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems
- EN 60601-2: Medical Electrical Equipment -- Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- EN 60601-1-4: Medical Electrical Equipment Part 1-4, General . Requirements for Safety – Collateral Standard: Programmable Electrical Medical Systems
- EN 60601-2-22: Medical Electrical Equipment -- Part 2: Particular . Requirements for Safety - Section 2.22: Specification for Diagnostic and Therapeutic Laser Equipment

### Summary of Non-Clinical Testing

No clinical evaluations of this product have been conducted.

## Statement of Equivalence

The Vari-Lase Endovenous Laser Console is substantially equivalent to the identified predicate devices based on a comparison of the indications for use and the technological characteristics.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three streams emanating from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions % Ms. Patrice Stromberg Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

NOV 2 1 2006

Re: K062822

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: II Product Code: GEX Dated: September 18, 2006 Received: September 20, 2006

Dear Ms. Stromberg:

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 complics 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 - Ms. Patrice Stromberg

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 yours

Sincerely yours

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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## Indications for Use Statement

510(k) Number (if known): K 062822

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, Offide & Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number 11 062722