DIOMED DELTA 25

K063828 · Diomed, Ltd. · GEX · Jan 25, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063828
• Device Name: DIOMED DELTA 25
• Applicant: Diomed, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures: General Surgery Ophthalmology/Oculoplastic Urology Gastroenterology Gynecology Otorhinolaryngology Pulmonary/Thoracic Dermatology/Plastic Surgery Neurosurgery (coagulation only) Orthopedic

Device Story

Diomed Delta 25 Laser is a Class IV InGaAs/AlGaAs diode laser system; delivers 1064nm wavelength radiation; includes 635-655nm visible aiming beam. Device outputs up to 25W of continuous wave or pulsed radiation via optical fiber. Used in clinical settings for soft tissue surgery; operated by physicians. Laser energy delivered to target tissue via flexible fiber; enables ablation, incision, excision, coagulation, and vaporization. Provides precise surgical control; benefits patients through minimally invasive endoscopic or open surgical options.

Clinical Evidence

Bench testing only. The device underwent a comprehensive series of test protocols to qualify and validate performance. Results demonstrated equivalent performance to predicate devices, which possess established clinical and market evidence of safety and effectiveness.

Technological Characteristics

Class IV InGaAs/AlGaAs diode laser; 1064nm ± 20 nm wavelength; 5mW Class IIIa 635-655nm aiming beam. Delivers up to 25W continuous wave or pulsed radiation. Fiber-coupled delivery system. Standalone surgical platform.

Indications for Use

Indicated for patients requiring soft tissue ablation, incision, excision, coagulation, or vaporization during open or endoscopic surgical procedures across various specialties including general surgery, ophthalmology, urology, gastroenterology, gynecology, ENT, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedics.

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 Delta 15 (K051996)
• Diomed Delta 30 (K051996)
• Adept 1064 Laser (K032218)
• Sciton Inc. Profile 1064 Laser System (K023881)
• Laserscope Lyra Surgical laser System (K020021)
• Spectrum Veinlase (K981952)

Submission Summary (Full Text)

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K063828

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14N 2 5 2007

### 510(k) Summary of Safety and Effectiveness for the Diomed Delta 25 Laser

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, Ltd.<br>Building 2000<br>Beach Drive<br>Cambridge Research Park<br>Waterbeach<br>Cambridge<br>CB5 9TE<br>United Kingdom |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Timothy G Phipps<br>Address as above<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | December 20th, 2006 |
| 2. Names | |
| Device Name: | Diomed Delta 25 Laser |
| Classification Name: | Laser Instrument, Surgical Powered |

## 3. Predicate Devices

The Diomed Delta 25 Laser is substantially equivalent in terms of its technological performance to:

- Diomed Delta 15 and Diomed Delta 30 (K051996) .
The Diomed Delta 25 Laser is substantially equivalent in terms of its laser wavelength performance to:

Product Code: GEX

Panel: Dermatology and Plastic Surgery

- . Adept 1064 Laser (K032218)
- Sciton Inc. Profile 1064 Laser System (K023881) .
- Laserscope Lyra Surgical laser System (K020021) .
- Spectrum Veinlase (K981952) .

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#### 4. Device Description

The purpose of this Special 510(k) is to notify FDA of the proposed inclusion of the Diomed Delta 25 Laser into Diomed's range of laser platforms. The Diomed Delta 25 Laser consists of a Class IV InGaAs/A1GaAs laser diode with a wavelength of 1064nm ± 20 nm and a visible laser (aiming beam) of 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm.

The Diomed Delta 25 Laser is made up of a treatment laser and aiming beam. The Diomed Delta 25 is a diode laser capable of delivering up to 25 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture. Drawings and photographs of the Diomed Delta 25 Laser are included in the operator manual found in Appendix G.

#### 5. Indications for Use

The Diomed Delta 25 Laser is intended for use in delivering up to 25 Watts of continuous wave or pulsed radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures.

#### 6. Performance Data

The Diomed Delta 25 laser has undergone a comprehensive series of test protocols in order to qualify and validate the performance of the device. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The Diomed Delta 25 is therefore validated for use on this basis.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diomed Ltd. % Mr. Tim Phipps OA/RA Director Building 2000, Beach Drive Cambridge Research Park Waterbeach Cambridge, United Kingdom CB5 9TE

JAN 2 5 2007

Re: K063828 Trade/Device Name: Diomed Delta 25 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: December 20, 2006 Received: December 26, 2006

Dear Mr. Phipps:

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

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Page 2 -- Mr. Tim Phipps

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.

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/industry/support/index.html.

Sincerely vo

for
Mark N. Melkerson

Mark N. Melkerson 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

K 063828 510(k) Number (if known): _______________

Diomed Delta 25 Device Name: __________

Indications For Use:

Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures:

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

Prescription Use AND/OR X (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)

| Concurrences of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------|-------------|
| Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | 2063828 |
| | Page 1 of 1 |