DIO-LIGHT LASER SYSTEM

K980201 · Nidek, Inc. · GEX · Mar 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980201
• Device Name: DIO-LIGHT LASER SYSTEM
• Applicant: Nidek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nidek Dio-Light Laser System is intended for all cleared Cynosure Photogenica LPIR applications. Treatment of vascular and pigmented lesions in Dermatology.

Device Story

The Nidek Dio-Light Laser System is a diode-based surgical laser used in dermatology. It functions by delivering laser energy to target and treat vascular and pigmented skin lesions. The device is intended for clinical use by healthcare professionals. It operates similarly to the predicate Cynosure Photogenica LPIR system, utilizing laser technology to achieve therapeutic effects on skin tissue. The system is designed for use in a clinical setting to assist physicians in dermatological procedures, providing a controlled method for lesion treatment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use comparisons to the predicate device.

Technological Characteristics

Diode-based surgical laser system. Complies with 21 CFR 1040.10 and 1040.11 performance standards for medical laser products. Class II device.

Indications for Use

Indicated for the treatment of vascular and pigmented lesions in dermatology.

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

• Cynosure Photogenica LPIR laser system

Submission Summary (Full Text)

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K48020/

MAR 1 6 1998

# SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK PRIMA KTP SURGICAL LASER SYSTEM

### REGULATORY AUTHORITY:

Safe Medical Devices Act of 1990, 21 CFR 807.92

## COMPANY NAME/CONTACT:

Ken Kato Vice President 47651 Westinghouse Drive Fremont, CA 94539 Phone: [phone] Fax: [phone]

DEVICE TRADE NAME:

Dio-Light Laser System

DEVICE COMMON NAME:

Laser Diode Surgical Laser System

#### DEVICE CLASSIFICATION:

Surgical laser systems are classified as Class II.

### PERFORMANCE STANDARDS:

The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.

INDICATIONS FOR USE STATEMENT:

Nidek Dio-Light Laser System is intended for all cleared Cynosure Photogenica LPIR applications.

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# COMPARISON WITH PREDICATE DEVICE:

The Nidek Dio-Light system is substantially equivalent to Cynosure's Photogenica LPIR laser system.

The risks and benefits of the Nidek Dio-Light are comparable to the predicate device when used for similar clinical applications.

Since the Nidek Dio-Light laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/2 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 representation of a human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998

Mr. Ken Kato ·Vice President Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539

Re: K980201 Trade Name: Dio-Light Laser System Regulatory Class: II GEX Product Code: Dated: January 16, 1998 Received: January 20, 1998

Dear Mr. Kato:

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 The general controls provisions of the Act 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. ದ 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 In addition, FDA may publish further announcements action. 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. Kato

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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Page 1 of 1

510(k) Number (if known): __ K 9 Jo 201

Device Name: Nidek Dio-Light Laser System

Indications for Use: Treatment of vascular and pigmented lesions in Dermatology.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K980201 |

| Prescription Use<br>(Pér 21 CFR 801.109) | OR | Over the Counter Use |
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