VARI-LASE PLATINUM BRIGHT TIP LASER FIBER

K091551 · Vascular Solutions, Inc. · GEX · Jun 19, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091551
• Device Name: VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 19, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Vari-Lase Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Story

The Vari-Lase Platinum Bright Tip is a laser fiber designed for endovenous laser treatment. It consists of a 600 um core laser fiber, a platinum/iridium distal tip, and an SMA connector. The device is compatible with solid-state diode laser consoles. It is used by clinicians in a clinical setting to treat venous insufficiency by delivering laser energy to the vein. The platinum/iridium tip provides visibility and durability during the procedure. The device is available in lengths between 2.4 and 3.6 meters with optional positioning marks. By facilitating targeted laser ablation, the device helps resolve venous reflux and associated symptoms, benefiting patients with varicose veins.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Laser fiber with platinum/iridium distal tip, 600 um core, and SMA connector. Lengths 2.4-3.6m, max diameter 0.038". Compatible with solid-state diode laser consoles. Non-sterile/sterile status not specified, but subject to standard manufacturing controls.

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 Bright Tip (K070216)

Submission Summary (Full Text)

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#### 510(k) Summary 2

Date Prepared: April 15, 2009

#### Submitter's Name / Contact Person

#### Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812

#### General Information

| Trade Name | Vari-Lase Platinum Bright Tip laser fiber |
|---------------------|---------------------------------------------------------|
| Common / Usual Name | Laser Fiber |
| Classification Name | 878.4810, Laser Instrument, Surgical, Powered |
| Predicate Device | K070216, Vari-Lase Bright Tip (Vascular Solution, Inc.) |

### Device Description

The Platinum Bright Tip is a laser fiber that is compatible with a solid state diode laser console. The laser fiber is comprised of a platinum/iridium distal tip, a 600 um core laser fiber and an SMA connector. The laser fiber lengths are between 2.4 meters and 3.6 meters, with a maximum diameter of 0.038". The laser fiber is available with or without positioning marks.

#### Intended Use / Indications

The Vari-Lase Platinum Bright Tip laser fiber 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.

### Substantial Equivalence and Summary of Studies

The Vari-Lase Platinum Bright Tip is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions.

O91SSI

## Contact Person

Loucinda Bjorklund Senior Regulatory Affairs Associate Tel: [phone] (direct); Fax: [phone] Email: 1bjorklund(@vascularsolutions.com

JUN 19 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

JUN 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Incorporated % Ms. Loucinda Bjorklund Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K091551

Trade/Device Name: Vari-Lase® Platinum Bright Tip Laser Fiber Regulation Number: 21 CFR 878.4810

Regulation Name: Laser Surgical Instrument for use in General Surgery and Plastic Surgery and in Dermatology

Regulatory Class: II Product Code: GEX Dated: May 26, 2009 Received: May 27, 2009

Dear Ms. Bjorklund:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting .

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Page 2-Ms. Loucinda Bjorklund

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

Mark N. Melkerson

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vascular Solutions, Inc.

# Indications for Use

ભ્ત દિવેલા દિવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયે 510(k) Number (if known):

Device Name: Vari-Lase® Platinum Bright Tip laser fiber

Indications for Use:

The Vari-Lase Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins in the lower extremity.

Prescription Use (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)

NulRPOgular for mkn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number Kogissl

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