LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR

• K Number: K063297
• Device Name: LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
• Manufacturer: LIGHTMED CORP.
• Date Cleared: 2007-09-20 ( 323 days)
• Product Code: HQF
• Regulation Number: 886.4390
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: K091981

Intended Use

The indications of use for this device are:

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

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for the LightLas 561 Ophthalmic Photocoagulator Laser. This kind of document typically does not contain the detailed study information you are asking for, as 510(k) applications demonstrate substantial equivalence to a predicate device rather than presenting full clinical trial data on device performance against acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and lists its "Indications for Use." It does not provide performance metrics or details of studies used to demonstrate specific performance against acceptance criteria for an AI/ML device. The device is a "Photocoagulator Laser," which is a physical medical device, not a software-based diagnostic or AI/ML product that would typically involve the kind of performance metrics and study design you're asking about (e.g., ground truth, reader studies, test/training sets for algorithms).

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

Page 4 -1

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
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.(b)
Classification. Class II.