VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE

K033237 · Vascular Solutions, Inc. · GEX · Nov 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033237
• Device Name: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VARI-LASE laser is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Device Story

The Vari-Lase Laser Console is a semiconductor diode laser system operating at 810 ± 20 nm. It is used by physicians in a clinical setting to treat varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein. The device delivers laser energy to the target tissue to induce thermal ablation. The physician operates the console to control energy delivery, which facilitates the closure of the vein. This minimally invasive procedure provides a therapeutic alternative to traditional surgical stripping, potentially reducing patient recovery time and procedural morbidity.

Clinical Evidence

Bench testing only. The device was verified for compliance with safety and performance standards including EN60601-1, EN60601-1-1, EN60601-1-2, EN60601-1-4, and EN60601-2-22.

Technological Characteristics

Semiconductor diode laser; 810 ± 20 nm wavelength. Complies with 21 CFR 1040 and EN60601 series standards (safety, electromagnetic compatibility, and programmable electrical medical systems).

Indications for Use

Indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

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

• Diomed 15/30 Plus Diomed, Inc. (K023543)
• Medart 425P/426 Laser Consoles (K991659)

Submission Summary (Full Text)

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NOV 2 0 2003

KO33232 - 1 - 1 6 - 1

## 510(K) SUMMARY

| Common/Usual Name: | Laser Instrument |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Trade Name: | Vari-Lase Laser Console |
| Classification Name: | Laser Surgical Instrument for use in General and Plastic Surgery and in<br>Dermatology 21 CFR 878-4810 (Product Code GEX) |
| Manufacturer: | Vascular Solutions, Inc.<br>2495 Xcnium Lane North<br>Minneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah Jensen<br>V. P., Regulatory Affairs, Clinical Affairs, and Quality Systems<br>[phone] phone<br>[phone] fax |
| Performance Standards: | No performance standards have been developed under section 514 for<br>this device. The laser console is in compliance with the standards<br>established in 21 CFR 1040. |
| Device Description: | The VARI-LASE Laser is a semiconducter diode laser operating at 810<br>± 20 nanometers. |
| Intended Use: | The VARI-LASE laser is indicated for the treatment of varicose veins<br>and varicosities associated with superficial reflux of the Greater<br>Saphenous Vein. |
| Summary of Non-Clinical<br>Testing: | Testing has been conducted to verify the laser console is in compliance<br>with the following standards: |
| EN60601-1 | Medical Electrical Equipment - Part 1: General Requirements For<br>Safety" |
| EN60601-1-1 | Medical Electrical Equipment - Part 1: General Requirements For Safety<br>1: Collateral Standard: Safety Requirements For Medical Electrical<br>Systems |
| EN60601-2 | Medical Electrical Equipment - Part 1-2: General Requirements For<br>Safety - Collateral Standard: Electromagnetic Compatibility - |
| EN60601-1-4 | Requirements And Tests<br>Medical Electrical Equipment - Part 1-4. General Requirements For |
| EN60601-2-22 | Safety - Collateral Standard: Programmable Electrical Medical Systems<br>Medical Electrical Equipment - Part 2: Particular Requirements For<br>safety - Section 2.22: Specification For Diagnostic And Therapeutic<br>Laser Equipment |
| Predicate Devices: | Diomed 15/30 Plus Diomed, Inc. (K023543)<br>Medart 425P/426 Laser Consoles (K991659) |
| Conclusions: | The VARI-LASE Laser is substantially equivalent to the identified<br>predicate devices based on a comparison of the indications for use<br>and the technological characteristics. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Ms. Deborah Jensen Vice President, Regulatory Affairs, Clinical Affairs and Quality Systems Vascular Solutions, Inc. 2495 Xenium Lane North Minneapolis, Minnesota 55441

Re: K033237

Trade/Device Name: Vascular Solutions 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 30, 2003 Received: October 7, 2003

Dear Ms. Jensen:

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 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 - Ms. Deborah Jensen

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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten. Ph.D.. M.D. 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:

033237

Device Name:

Vascular Solutions Vari-Lase™ Endovenous Laser Console

Indications for Use:

VARI-LASE is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Miriam

(Division Sign-Off) (Division Sigil-On)
Division of General, Restorative Division of Sical Devices

< 033237 510(k) Number -