DIOMED 15 PLUS AND DIOMED 30PLUS LASERS

K013499 · Diomed, Inc. · GEX · Nov 16, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013499
• Device Name: DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
• Applicant: Diomed, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diomed 15plus and 30plus Lasers are intended for use in delivering 15 or 30 watts of laser radiation to a flexible optical fiber or spot hand piece for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures.

Device Story

Diomed 15plus and 30plus are modified Class IV Gallium Aluminum Arsenide diode lasers; intended for soft tissue ablation, incision, excision, coagulation, and vaporization. Devices accept input via fiber delivery system or spot handpiece. Modifications include shorter pulse duration (50 ms), addition of spot handpiece/software delivery system, and Fluence Display to improve delivery accuracy. Power meter added to 15plus model. Operated by physicians in surgical settings. Output is laser radiation delivered to treatment site. Benefits include enhanced clinical efficiency and improved accuracy of delivered power/fluence.

Clinical Evidence

Bench testing only. Verification and validation testing performed to confirm modified devices function as intended.

Technological Characteristics

Class IV Gallium Aluminum Arsenide (GaAlAs) diode laser. Fiberoptic and spot handpiece delivery modes. Features include 50 ms pulse duration, Fluence Display, and power meter. Standalone device.

Indications for Use

Indicated for contact and non-contact soft tissue applications in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic procedures.

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 and Diomed 30 Lasers (K962354)

Submission Summary (Full Text)

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# 510(k) Summary KO13499 for NOV 1 6 2001 Diomed 15plus and Diomed 30plus Lasers

#### SPONSOR 1.

| Diomed Inc. |
|---------------|
| 1 Dundee Park |
| Suite 5/6 |
| Andover |
| MA 01810 |
| USA |

| Contact Person: | Angie Glover |
|-----------------|---------------------|
| Telephone: | 011 44 1223 729 337 |

October 19, 2001 Date Prepared:

#### DEVICE NAME 2.

| Proprietary Name: | Diomed 15plus and Diomed 30plus Lasers |
|----------------------|----------------------------------------|
| Common/Usual Name: | Surgical Lasers |
| Classification Name: | Laser Surgical Instruments |

#### PREDICATE DEVICES 3.

Diomed 15 and Diomed 30 Lasers -K962354

#### DEVICE DESCRIPTION 4.

The Diomed 15plus and Diomed 30plus Lasers are modified versions of the Diomed 15 and Diomed 30 lasers. A shorter pulse duration (50 ms) has been added to both the 15plus and 30plus lasers. The modified devices include a spot handpiece/software delivery system in addition to a fiber delivery system.

A Fluence Display has been added to enhance the efficiency of existing clinical indications when using the spot hand piece. A power meter (currently used in the

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Diomed 30 laser) has been added to the Diomed 15plus laser to improve the accuracy of delivered powcr/fluence to the treatment site.

### INTENDED USE న.

The Diomed 15plus and 30plus Lasers are intended for use in delivering 15 or The Diomed reports wave radiation to a flexible optical fiber or spot hand piece for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Diomed 15plus and Diomed 30plus Lasers and the original Diomed 15 and The Diomed 30 Lasers all consist of a Class IV Gallium Aluminum Arsenide diode Diomed 30 Laster ming beam. The original Diomed 15 and Diomed 30 lasers offer a fiberoptic mode while the modified Diomed 15plus and Diomed 30plus offers both a fiberoptic and spot handpiece mode.

The Diomed 15plus and Diomed 30plus Lasers and the Diomed 15 and Diomed The Diomes all have essentially identical performance characteristics except for Both the Diomed 15plus and Diomed slight changes to the pulse duration. signe changes to the predicate devices offer a fiberoptic mode. Additionally, the proposed device offers a spot mode.

## PERFORMANCE TESTING 7.

Verification and validation testing was successfully performed to confirm that the modified Diomed 15plus and Diomed 30plus Lasers function as intended.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with three winding lines, representing health and medicine.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diomed, Inc. c/o Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

NOV 1 6 2001

Re: K013499

Trade/Device Name: Diomed 15plus and Diomed 30plus Lasers 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 19, 2001 Received: October 22, 2001

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premainer nevinstantially equivalent (for the indications for use stated in the enclosure) the avential the aveces and the second of the states and managements for use stated in the encrosule) to regally manative provice Amendments, or to commerce prof to May 20, 1976, the enational with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require approvise to the general controls provisions of the Act. The You may, therefore, market the abtires, octorements for annual registration, listing of general controls provisions of the free merado required on against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller L. Ranger Provents 800 to 898. In addition, FDA may be found in the Oouveements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that I Dri brissame at your device complies with other requirements of the Act that IDA has made a colorimiations administered by other Federal agencies. You must of any I cacal statutes and regairements, including, but not limited to: registration and listing (21 Comply with an the Free 5 requirements, as and manufacturing practice requirements as set CFN Fall 807), labeling (21 OFR Part 820), government
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by telems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Mary McNamara-Cullinane

This letter will allow you to begin marketing your device as described in your Section 510(k)
The Children Carling of Clines of a local started assivelence of your device to This letter will allow you to begin harksmig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaliae and this p premarket notification. The PDA Inding of substantial equivalier and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do vito diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vites diagnostic devices the momotion additionally 21 CFR Part 809.10 to minio unances an the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and advertisi Compliance at [phone]. Additionally, to: quest.is or state of any 16 the Part the your device, piease contact the Chrysler of remarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to the Anney has obtained from the regulation entitled, "Misoranding by reference to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Binan Mon) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

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):

K013499

Device Name: Diomed 15plus and Diomed 30plus Lasers

NOV 1 6 2001

Indications For Use:

The Diomed 15plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue applications:

- General Surgery .
- Ophthamology/Oculoplastic .
- Urology
- Gastroenterology
- Gynecology
- Otorhinolaryngology
- Pulmonary/Thoracic
- Dermatology/Plastic Surgery
- Neurosurgery (coagulation only)
- Orthopedic

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lisa Wall

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

510(k) Number K013499

Prescription Use
(Per 21 CFR 801.109)

OR

Over- The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Diomed Inc. Special 510(k) Diomed 15plus and Diomed 30plus Lasers October 19, 2001

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