LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR

K063297 · Lightmed Corp. · HQF · Sep 20, 2007 · Ophthalmic

Device Facts

• Record ID: K063297
• Device Name: LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
• Applicant: Lightmed Corp.
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Retinal Photocoagulation ● Pan Retinal Photocoagulation ● Macular Photocoagulation . Laser Trabeculoplasty . - Laser trabeculoplasty is photocoagulation of trabecular meshwork to treat o Open Angle Glaucoma (OAG). - Endocoagulation .

Device Story

LightLas 561 Ophthalmic Photocoagulator Laser is a medical laser system used by ophthalmologists in clinical settings. Device delivers 561 nm wavelength laser energy to ocular tissues to perform photocoagulation procedures. System consists of laser console, delivery system, and control interface. Physician operates device to target specific retinal or trabecular meshwork areas; laser energy induces thermal coagulation to treat conditions like open-angle glaucoma or retinal pathologies. Output is controlled laser beam; clinical benefit includes non-invasive or minimally invasive treatment of ocular diseases by creating therapeutic lesions in target tissues.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ophthalmic photocoagulator laser; 561 nm wavelength; Class II device; 21 CFR 886.4390; Product Code HQF. System includes laser console and delivery optics. Operates via thermal coagulation of ocular tissue.

Indications for Use

Indicated for patients requiring retinal, pan-retinal, or macular photocoagulation, endocoagulation, or laser trabeculoplasty for the treatment of open-angle glaucoma (OAG).

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2007

LightMed Corporation % Mr. Gary Lee President & CEO No. 1-1, Lane1, Pao-An St. Sec. 3 Shulin City, China (Taiwan) 238

Re: K063297

Trade/Device Name: LightLas 561 Ophthalmic Photocoagulator Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Opthalmic laser Regulatory Class: II Product Code: HQF Dated: July 5, 2007 Received: July 9, 2007

Dear Mr. Lee:

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 (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.

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Page 2 - Mr. Gary Lec

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 yours.

Mark N Millerson

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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## Section 4

## Indications for Use Statement

510(k) number (if known): k063297

Device Name: _LightLas 561 Ophthalmic Photocoagulator Laser

Indications for use:

The indications of use for this device are:

- Retinal Photocoagulation ●
- Pan Retinal Photocoagulation ●
- Macular Photocoagulation .
- Laser Trabeculoplasty .

Mark N. Milkerer

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

510(k) Number

Number K063297

- Laser trabeculoplasty is photocoagulation of trabecular meshwork to treat o Open Angle Glaucoma (OAG).
- Endocoagulation .

Prescription Use (X) (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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