DIOMED 15 DIODE LASER

K012398 · Diomed, Ltd. · GEX · Jan 22, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K012398
• Device Name: DIOMED 15 DIODE LASER
• Applicant: Diomed, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Device Story

Device consists of semiconductor diode laser (810 nm) and associated disposables; used for endovascular coagulation of greater saphenous vein. Laser energy delivered via fiber optic to target vein; thermal energy induces coagulation/occlusion of vein. Used in clinical setting by physicians; procedure treats superficial vein reflux. Output is laser light energy; clinical benefit is minimally invasive treatment of venous insufficiency.

Clinical Evidence

Clinical tests performed by the manufacturer demonstrated substantially equivalent performance to the predicate device for the indicated use.

Technological Characteristics

Semiconductor GaAlAs diode laser; wavelength 810 ± 20 nm. Includes associated disposables for endovascular access and delivery. Operates as a surgical laser instrument.

Indications for Use

Indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

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

• VNUS Closure System (K974521, K003092, K982816)

Submission Summary (Full Text)

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K012398

## 510(K) SUMMARY Diomed 810 nm Surgical Lasers and EVLT Procedure Kit

This 510(k) summary of safety and effectiveness for the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Diomed, Inc. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | One Dundee Park<br>Suite 5/6<br>Andover, MA 01810 |
| Contact Person: | Peter Klein<br>Chief Executive Officer |
| Telephone: | 978-475-7771<br>978-475-8488 (fax) |
| Preparation Date:<br>(of the Summary) | January, 2002 |
| Device Name: | Diomed 810 nm Surgical Lasers and EVLT Procedure Kit |
| Common Name: | Surgical Laser: GaAlAs Semiconductor Diode Laser |
| Classification<br>Name: | Device, Electrosurgical, Cutting & Coagulation & Accessories<br>(see: 21 CFR 878.4400). Product Code: GEI. Panel: 79 |
| Legally marketed<br>predicate<br>device: | VNUS Closure System (K974521, K003092, K982816) |
| Description of<br>the Device: | Diomed 810 nm Surgical Lasers and EVLT Procedure Kit<br>is a semiconductor diode lasers operating at 810 ± 20 microns and<br>associated disposables. |
| Indications for<br>Use: | Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are<br>intended for use in endovascular coagulation of the greater<br>saphenous vein of the thigh in patients with superficial vein reflux. |
| Comparison to<br>Predicate Device: | The intended use, method of tissue interaction, specifications,<br>clinical technique and clinical results of the Diomed 810 nm<br>Surgical Lasers and EVLT Procedure Kit are the same or very<br>similar to those of the claimed predicate. |
| Performance Data: | Clinical tests performed by Diomed have demonstrated the<br>substantially equivalent performance of the Diomed 810 nm<br>Surgical Lasers and EVLT Procedure Kit with the predicate device<br>used for substantially equivalent indications. |
| Conclusion: | Based on the foregoing, Diomed believes that the Diomed 810 nm<br>Surgical Lasers and EVLT Procedure Kit are substantially<br>equivalent to legally marketed predicate devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures connected at the shoulders, forming a symbolic representation of people.

JAN 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diomed, Ltd. c/o Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K012398

R012376
Trade/Device Name: Diomed 810 nm Surgical Lasers and EVLT Procedure Kit Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 22, 2001 Received: October 24, 2001

Dear Mr. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to stgmay to the Medical Device Amendments, or to commerce proc to rias 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Four may, ateres, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elassinon (controls. Existing major regulations affecting your device can may or babyer 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 r read of a nove a determination that your device complies with other requirements of the Act that I Dr Has Intatutes 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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

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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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ K012398

Device Name: Diomed 810 nm Surgical Lasers and EVLT Procedure Kit

Indications For Use:

Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in Dromed of 0 mm burgiour Dasers and 24 saphenous vein of the thigh in patients with superficial vein reflux.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

ાર ounter Use Division Sign-Off

Division of General Restorative and Neurological L vices

510(k) Number K012-398

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 810.109)