EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS

K041957 · Diomed, Inc. · GEX · Dec 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041957
• Device Name: EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
• Applicant: Diomed, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Story

Diode laser system (D15Plus/D30Plus) delivers pulsed or continuous wave radiation via fiber optic handpiece/optical fiber. EVLT procedure kit includes bare tip fiber (400-1000 micron), introducer sheath (4-5 Fr), percutaneous entry needle (19G), and guide wire (0.035"). Used by physicians in clinical settings for endovenous laser treatment of superficial vein reflux. Laser energy induces thermal ablation of the vein; output controlled by physician to treat incompetent veins. Benefits include minimally invasive management of lower extremity varicosities.

Clinical Evidence

Clinical data presented on 213 subjects treated with the Diomed D15Plus Laser System and EVLT Kit for endovenous laser treatment.

Technological Characteristics

Diode laser; pulsed radiation (up to 119 J/cm² for D15Plus, 400 J/cm² for D30Plus) or continuous wave (0.5-15 W for D15Plus, 0.5-30 W for D30Plus). Fiber optic delivery system. Components include bare tip fiber, introducer sheath, percutaneous needle, and guide wire.

Indications for Use

Indicated for treatment of superficial vein reflux and incompetence in the lower extremity, specifically the greater saphenous vein associated with varicosities.

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 EVLT Kit and D15Plus and D30Plus Diode Lasers (K023543)
• Diomed 810 nm Surgical Lasers and EVLT Procedure Kit (K012398)
• Diomed 15Plus and Diomed 30Plus Lasers (K013499)

Submission Summary (Full Text)

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# DEC - 1 2004

#### 510(k) Summary of Safety and Effectiveness for the × 04195 Diomed, Inc. EVLT Kit and D15Plus and D30Plus Lasers

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

#### 1. General Information

| Submitter: | Diomed, Inc.<br>One Dundee Park, Suites 5 and 6<br>P.O. Box 97<br>Andover, MA 01810 |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | November 16, 2004 |
| 2. Names. | |
| Device Name: | EVLT Kit and D15Plus and D30Plus Lasers |
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>Panel: Dermatology and Plastic Surgery |

### 3. Predicate Devices

The EVLT Kit and the D15Plus and D30Plus Lasers are substantially equivalent to the Diomed EVLT Kit and D15Plus and D30Plus Diode Lasers (K023543), the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit (K012398) and the Diomed 15Plus and Diomed 30Plus Lasers (K013499).

#### 4. Device Description

The DIOMED 15 Plus is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The DIOMED 30 Plus is a diode laser capable of delivering up to 400 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-30 W of continuous wave radiation via an optical fiber coupled to the laser aperture.

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An EVLT procedure kit is available which may contains a 400 -1000 micron corc, 2.5 meter long bare tip fiber with location markers, a 25-100 cm long, 4- 5 Fr graduated introducer sheath with dilator, a 19 Gauge, 7 cm percutaneous entry needle, and a 0.035" J guide wire.

### 5. Indications for Use

The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

#### 6. Performance Data

Clinical data was presented on 213 subjects treated with endovenous laser treatment with the Diomed D15Plus Laser System and EVLT Kit.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Diomed Inc. C/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K041957

K041937
Trade/Device Name: EVLT Kit and D15 Plus and D30 Plus Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFR 076.1010
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 15, 2004 Received: October 18, 2004

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bection 910(t) premained is substantially equivalent (for the indications felerenced above and nave determined and and and and and one of the marketed in interstate for use stated in the clerosule) to regally manat date of the Medical Device Ameradments, or to commerce prior to May 28, 1976, the enaeminen with the provisions of the Federal Food. Drug, devices mat have been recalismou in accerative approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval alle Costine Act (Tec) that do not requent of the general controls provisions of the Act. The f ou may, therefore, market the dorres, becject of the ments for annual registration, listing of general controls provisions of the rist 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 classified (600 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devilsed that I Drissan that your device complies with other requirements of the Act that I DA has made a as a regulations administered by other Federal agencies. You must or any I cuttar statures und regaranents, including, but not limited to: registration and listing (21 Compry with an the Her Stequirements, and manufacturing practice requirements as set CFR Part 607), adoning (21 OF R Part 820); and if applicable, the electronic form in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Maureen O'Connell

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter war a my way tinding of substantial equivalence of your device to a legally premainst notification "The 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 If you attire 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of The 8 runn Diomed Laser and Ever 1 roceans the are nother with varicosities. The Diomed D15 superilicial vein reliux of the greater suphonous for treatment of incompetence and reflux of superficial veins in the lower extremity.

AND/OR X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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**510(k) Number** k041957