DIOSCAN

K990014 · Diomed, Inc. · GEX · Feb 26, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990014
• Device Name: DIOSCAN
• Applicant: Diomed, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.

Device Story

DioScan Scanning Handpiece Accessory is a laser delivery system accessory for surgical lasers. It enables rapid treatment of large skin areas by scanning a laser spot across the treatment site. The device features a sapphire window in thermal contact with the skin to provide cooling, which minimizes patient discomfort and reduces thermal damage. It is intended for use by clinicians in dermatology and plastic surgery settings. The device functions as a mechanical delivery interface for existing laser surgical instruments.

Clinical Evidence

No clinical data. Performance data were not required as the device is substantially equivalent to legally marketed predicates with similar indications for use.

Technological Characteristics

Laser handpiece delivery system; features a sapphire window for contact cooling; designed for use with laser surgical instruments; mechanical scanning mechanism for laser spot distribution.

Indications for Use

Indicated for incision, excision, vaporization, ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.

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

• Lihtan Technologies, Inc. Hexascan Handpiece
• Cool Laser Optics, Inc. CLO Contact Cooling System

Submission Summary (Full Text)

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2/26/95

## 996014

Appendix E

## 510(K) SUMMARY DIOSCAN SCANNING HANDPIECE ACCESSORY

This 510(k) summary of safety and effectiveness for the handpiece accessory is submitted in accordance I his 510(K) summaly of sacty and circultions office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Diomed, Inc. |
|------------|--------------|
|------------|--------------|

- 30-31 Union Wharf Address: Boston, MA 02109
- Contact Person: Adrian Grundy General Manager
- 617-723-6593 Telephone: [phone] (fax)

Preparation Date:December, 1998 (of the Summary)

DioScan Scanning Handpiece Accessory Device Name:

Common Name: Laser Handpiece Delivery System

Accessory to a laser surgical instrument for use in general and plastic surgery and in Classification dermatology Name: (see: 21 CFR 878.4810). Product Code: GEX. Panel: 79.

Legally marketed

| predicate | |
|-----------|----------------------------------------------------------------------------------------------------|
| device: | Lihtan Technologies, Inc. Hexascan Handpiece<br>Cool Laser Optics, Inc. CLO Contact Cooling System |

- The DioScan Scanning Handpiece is intended to allow the rapid treatment of a large Description of area of skin by scanning a laser spot over a treatment area. The area treated allows the the Device: majority of the operator's time to be spent in treatment, with a small proportion of time spent in moving the scanner between areas. To minimize patient discomfort and reduce spent in moving the counter ous, the handpiece employs a cooled sapphire window in thermal contact with the skin during treatment.
- The DioScan Scanning Handpiece Accessory is indicated for incision, excision, Indications for I he Diocoan. Obtaining sutting, hemostasis, and coagulation of soft tissue in dermatology use: and plastic surgery, including aesthetic surgery.
- The specifications of the DioScan Scanning Handpiece Accessory are the same or very Comparison to: similar to those of the claimed predicates.

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- None. The specifications and indications for use of the DioScan Scanning Handpiece Performance Accessory are the same or very similar to those of the claimed predicate devices. The Data: DioScan Scanning Handpiece Accessory has similar indications for use for which the claimed predicates have been cleared.
Because of this, performance data were not required.

- Based on the foregoing, Diomed believes that the DioScan Scanning Handpiece Conclusion: Accessory is substantially 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 stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Mr. Adrian Grundy General Manager Diomed, Inc. 30-31 Union Wharf Boston, Massachusetts 02109

K990014 Re: Trade Name: DioScan Scanning Handpiece Accessory Regulatory Class: II Product Code: GEX Dated: December 30, 1998 Received: January 4, 1999

Dear Mr. Grundy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Adrian Grundy

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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990014 510(K) Number (if known):

Device Name: DioScan Scanning Handpiece Accessory

Indications For Use:

The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, The DioScan Scaming Hampico Accossery is marketed to consisted, "
ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use (Per 21 CFR 810.109) 36