GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

K032085 · Nidek, Inc. · GEX · Oct 3, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032085
• Device Name: GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
• Applicant: Nidek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Device Story

Nidek GYC-1000 is a frequency-doubled diode-pumped solid-state (DPSS) laser system for ophthalmic photocoagulation. It emits a 532 nm green therapeutic laser beam aligned with a 635 nm red diode aiming beam. The system uses fiber-optic cables to deliver laser energy to various delivery units, including slit lamps, indirect ophthalmoscopes, and endophotocoagulation probes. Operated by ophthalmologists in clinical settings, the device allows precise coagulation of target ocular tissue. A protective filter in the observation path shields the operator from reflected laser light. The system features a dual-CPU architecture (master for control, sub for monitoring) to ensure safe operation. By enabling targeted photocoagulation, the device assists in treating retinal/macular conditions and glaucoma, potentially preserving or improving patient vision.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2), programmable electrical medical systems (EN 60601-1-4), and laser safety standards (IEC 60601-2-22, JIS T1204, JIS C6802).

Technological Characteristics

DPSS laser, 532 nm wavelength; 50-1700mW power output; continuous wave mode. Air-cooled. Dual-CPU architecture (master/sub). Delivery via fiber-optic cable to slit-lamp, indirect ophthalmoscope, or endoprobe. Aiming beam: 635 nm diode laser. Complies with EN 60601-1, EN 60601-1-2, EN 60601-1-4, IEC 60601-2-22, JIS T1204, and JIS C6802.

Indications for Use

Indicated for patients requiring ophthalmic surgical procedures, specifically retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

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

• Nidek Laser Photocoagulator Model GYC-1500/2000 (K980547)

Submission Summary (Full Text)

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# KO32087 510(k) SUMMARY NIDEK GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

#### SUBMITTER INFORMATION 1.

| A. | Company Name: | Nidek Incorporated |
|----|------------------------|-----------------------------------------------------------------------|
| B. | Company Address: | 47651 Westinghouse Drive.<br>Fremont, CA 94539-7474 |
| C. | Company Phone: | [phone] |
| | Company Fax: | [phone] |
| D. | Contact Person: | Mr. Hiro Matsuzaki<br>Regulatory and QA Manager<br>Nidek Incorporated |
| E. | Date Summary Prepared: | October 1, 2003 |

#### 2. DEVICE IDENTIFICATION

| A. | Classification Name: | Ophthalmic Laser, and Powered Surgical Laser<br>Instrument |
|----|-------------------------|------------------------------------------------------------|
| B. | Trade/Proprietary Name: | Nidek Green Laser Photocoagulator<br>Model GYC-1000 |
| C. | Device Classification: | Class II (per 21 CFR 886.4390 and 878.4810) |
| D. | Product Code: | HQF and GEX |

# SUBSTANTIAL EQUIVALENCE 3.

The Nidek Green Laser Photocoagulator Model GYC-1000 is of comparable type and is substantially equivalent to the following predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|----------------------------------------------------|-------------------------|------------|--------------|
| Nidek Laser Photocoagulator<br>Model GYC-1500/2000 | Nidek Co. Ltd.<br>Japan | K980547 | May 13, 1998 |

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The fundamental technical characteristics and device specifications of the Nidek Green Laser Photocoagulator Model GYC-1000 are the same as those of the predicate device. The Model GYC-1000 and the predicate device are frequency doubled solidstate lasers with a wavelength of 532 nm. The Model GYC-1000 and the predicate device use a variety of delivery systems, including slit lamps, indirect ophthalmoscopes, endoprobes, and Nd: Y AG lasers to deliver the laser beam. The Model GYC-1000 and the predicate device are indicated for use in macular and retinal photocoagulation, and glaucoma procedures such as iridotomy and trabeculoplasty.

#### 4. DEVICE DESCRIPTION

The Nidek Green Laser Photocoagulator Model GYC-1000 is a frequency doubled diode pumped solid state (DPSS) laser ophthalmic photocoagulation system that produces a 532 nm (green) wavelength light as the treatment beam. The Model GYC-1000 uses a diode laser (red) with a wavelength of 635 nm as the aiming beam. The green laser beam is aligned with the red aiming laser beam in the optical system inside the unit and gathers them in a fiber-optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

The Model GYC-1000 can be used to coagulate the target tissue efficiently and safely, and the system can be applied to transpupillary photocoagulation procedures using a slit-lamp or indirect ophthalmoscope and intraocular photocoagulation procedures using an endophotocoagulation probe. The Model GYC-1000 is a smaller, modified version of the Models GYC-1500 and GYC-2000, which were the subject of premarket notification number K980547.

A protective filter may be attached to each delivery unit in the observation optical path so that the operator's eye can be protected from the laser beam if it is reflected

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from a patient's eve or contact lens during laser emission. The Model G Y C-1000 has a number of delivery units available for use in a variety of ophthalmic procedures:

- Endophotocoagulation Delivery Unit .
- NIDEK Slit-Lamp Delivery Unit
- ZEISS Slit-Lamp Attachable Delivery Unit ●
- HAAG Attachable Slit-Lamp Delivery Unit .
- Binocular Indirect Ophthalmoscope Delivery Unit .
- Combination Delivery Unit for Nidek Nd:YAG laser .

# 5. INDICATIONS FOR USE

The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

# TECHNOLOGICAL CHARACTERISTICS 6.

A comparison of the technological characteristics of the Nidek Green Laser Photocoagulator Model GYC-1000 and the predicate device has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the Nidek Green Laser Photocoagulator Model GYC-1000 has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device. The differences between the Nidek Green Laser Photocoagulator Model GYC-1000 and the predicate device are insignificant and do not affect the safety or effectiveness of the device.

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| | Nidek Model GYC-1000 | Nidek GYC-1500/2000<br>K980547 (Predicate Device) |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Laser | Laser diode pumped,<br>frequency doubled Nd:YAG<br>solid state laser | Model GYC-1500: Arclamp<br>(Krypton) pumped, frequency<br>doubled Nd:YAG solid state laser<br><br>Model GYC-2000: Laser diode<br>pumped, frequency doubled<br>Nd:YAG solid state laser |
| Wavelength | 532 nm | 532 nm |
| Output | Continuous Wave | Continuous Wave |
| Power Output | 50 to 1700mW<br>(50 to 500mW in 10mW<br>increments,<br>500 to 1700mW in 50mW<br>increments) | 50 to 1500mW in 10mW<br>increments (Model I)<br>or<br>50 to 2000mW in 10mW<br>increments (Model II) |
| Exposure Time | 0.01 to 0.10 sec. in 0.01 sec.<br>increments<br>0.10 to 0.50 sec. in 0.05 sec.<br>increments<br>0.50 to 1.00 sec. in 0.10 sec.<br>increments<br>1.00 to 3.00 sec. in 1.00 sec.<br>increments | 0.02 to 3.00 sec. |
| Repetition Mode | Interval time 1.0 to 0.1 sec. in<br>0.1 sec. increments | 1.0, 0.6, 0.4 and 0.2 sec. |
| Cooling Method | Air cooled | Internal water cooling system |
| Microprocessor | Two CPU's: Master CPU for<br>controlling the device, and Sub<br>CPU for monitoring the<br>Master CPU | One CPU |
| Aiming Laser | | |
| Type | Diode Laser | Diode Laser |
| Wavelength | 635 nm (red) | 633 nm (red) |
| Output Type | Continuous Wave | Continuous Wave |
| Power Output | 0.2 to 0.4mW | 0.2 to 0.8mW |
| Accessories | | |
| Endophotocoagulation Delivery<br>Unit | Straight and angled probes,<br>which are single-use<br>disposable | Straight and angled probes, which<br>are single-use disposable |
| Slit Lamp Delivery Unit | Nidek SL-1600 Type | Nidek SL-1600 Type |
| Slit Lamp Adaptors | Zeiss Type<br>• | Zeiss Type<br>• |
| PREDICATE DEVICE COMPARISON TABLE | | |
| | Nidek Model GYC-1000 | Nidek GYC-1500/2000<br>K980547 (Predicate Device) |
| Binocular Indirect<br>Ophthalmoscope (B.I.O.)<br>Delivery Unit | Haag Streit Type Heine Omega 180 Type | Haag Streit Type Heine Omega 180 Type |
| Combination Delivery Unit | For use with Nidek Nd:YAG<br>lasers | For use with Nidek Nd:YAG<br>lasers |
| Spot Size at Target | 50 to 500 µm (parfocal) for Combination Unit and<br>Slit Lamp Units 180 to 520 µm for B.I.O. 400 µm for Endo probes | 50 to 500 µm (parfocal) for<br>Combination Unit and Slit<br>Lamp Units 180 to 520 µm for B.I.O. 400 µm for Endo probes |
| Operating Microscope Filters | Zeiss Möeller Wedel Topcon Wild | Zeiss Möeller Wedel Topcon Wild |
| Power Requirements | 90-264 VAC, 50/60 Hz,<br>200 VA | 100/120/230 VAC, 50/60 Hz,<br>1500 VA (continuous) |

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# 7. PERFORMANCE DATA

System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. The following testing was performed on the Nidek Green Laser Photocoagulator Model GYC-1000 to demonstrate that it meets all specified requirements and is equivalent to the predicate device:

A. Electrical Safety Testing & Electromagnetic Compatibility

> The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.

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- Programmable Electrical Medical Systems B.
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard.

- C. Requirements For The Safety Of Diagnostic And Therapeutic Laser Equipment
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with IEC 60601-2-22, JIS T1204, and JIS C6802, and was found to meet all requirements of the standards.

# 8. CONCLUSIONS

Nidek Incorporated has demonstrated through its evaluation of the Nidek Green Laser Photocoagulator Model GYC-1000 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2003

Mr. Hiro Matsuzaki Regulatory and QA Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, CA 94539-7474

Re: K032085

Trade/Device Name: Nidek Green Laser Photocoagulator Model GYC-1000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatiology Regulatory Class: II Product Code: GEX Dated: July 1, 2003 Received: July 7, 2003

Dear Mr. Matsuzaki:

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 quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Hiro Matsuzaki

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/dsma/dsmamain.html

Sincerely yours,

Muriam 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: | K032085 (To Be Assigned By FDA) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Nidek Green Laser Photocoagulator Model GYC-1000 |
| Indications For Use: | The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. |

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use

Miriam C Provost

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

510(k) Number K032085

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