NIDEK MULTICOLOR LASER PHOTOCOAGULATOR

K110228 · Nidek Incorporated · HQB · Feb 23, 2011 · Ophthalmic

Device Facts

• Record ID: K110228
• Device Name: NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
• Applicant: Nidek Incorporated
• Product Code: HQB · Ophthalmic
• Decision Date: Feb 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Device Story

The MC-500 is an ophthalmic laser photocoagulator system used by ophthalmologists in clinical settings. It utilizes diode aim and treatment lasers with wavelengths of 532 nm, 577 nm, and 647 nm to deliver therapeutic energy to ocular tissues. The system includes a graphical user interface, a slit lamp, a binocular indirect ophthalmoscope for delivery, and a footswitch for operator control. The physician uses the system to perform precise photocoagulation, iridotomy, or trabeculoplasty procedures. The device output is controlled laser energy, which the physician directs to the target tissue to achieve the desired therapeutic effect, such as treating retinal or macular conditions or managing glaucoma through iridotomy/trabeculoplasty.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ophthalmic laser photocoagulator system. Wavelengths: 532 nm, 577 nm, 647 nm. Components: diode aim and treatment lasers, graphical user interface, slit lamp, binocular indirect ophthalmoscope, footswitch.

Indications for Use

Indicated for ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Regulatory Classification

Identification

An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.

Predicate Devices

• Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785)

Submission Summary (Full Text)

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Nidek, Inc.

# SECTION 6 510(k) SUMMARY (CONT.)

# 510(k) Notification K_ K ( ( 022 P

FEB 2 3 2011 :

#### GENERAL INFORMATION

Applicant:

Nidek Incorporated 47651 Westinghouse Drive Fremont, CA 94539-7474 U.S.A. Phone: [phone] Fax: [phone]

#### Contact Person:

Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: [phone] ext. 112 Fax: [phone] Email: [e-mail]

Date Prepared: January 24, 2011

#### Classification:

21 CFR§878.4810 and §886.4390, Class II

#### Product Code: GEX, HQF

Trade Name: Nidek Multicolor Laser Photocoagulator System MC-500

# Generic/Common Name:

Ophthalmic Laser Photocoagulator

#### Predicate Device

Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785)

#### Intended Use

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

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## SECTION 6 510(k) SUMMARY (CONT.)

### Product Description

The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.

#### Substantial Equivalence

The MC-500 is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed MC-500 is substantially equivalent to the predicate device.

# Testing in Support of Substantial Equivalence Determination

All necessary bench testing was conducted on the proposed MC-500 to support a determination of substantial equivalence to the predicate device.

#### Summary

The MC-500 is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Nidek Incorporated % Experien Group, LLC Kit Cariquitan 155-A Moffett Park Drive, Suite 210 Sunnyale, California 94089

FEB 2 3 2", 1

Re: K110228

Trade/Device Name: Nidek Multicolor Laser Photocoagulator System MC-500 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: January 24, 2011 Received: January 26, 2010

Dear Kit Cariquitan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Kit Cariquitan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aty B. R. to
ken

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NIDEK, INC.

## SECTION 5 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Nidek Multicolor Laser Photocoagulator System MC-500

# Indications for Use:

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

N.L. the
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110228