The LightLas 577 Medical Optical Pumped Semiconductor Laser is intended for use in ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

. Retinal Photocoagulation
Pan Retinal Photocoagulation .
Endophotocoagulation ●
Macular Photocoagulation
Laser Trabeculoplasty (to treat Open Angle Glaucoma)

Device Description

The LightLas 577 Laser beam has a wavelength of 577mm, which is in the visible spectrum and is a Yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.

The LightLas 577 is a solid state, Optical Pumped Semiconductor surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 577nm.

LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 577 retinal photocoagulator to allow use of the slit lamp to deliver 577 nm continuous wave laser energy for retinal photocoagulation.

Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the request regarding acceptance criteria and study data for the LightLas 577 Medical Optical Pumped Semiconductor Laser.

The text is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices and regulatory compliance.

Here's what is missing from the provided text that would be needed to answer your questions:

Specific Acceptance Criteria: The document states "The appropriate testing including safety, performance and functional testing to determine The appropriate testing methoding Laser System." but it does not list what those acceptance criteria were for performance metrics.
Reported Device Performance: While it mentions testing was done, it does not provide any quantitative results or data on the device's performance against any specific metrics.
Details of the Study: There is no description of any specific study (clinical, standalone, or MRMC) that was conducted to prove the device meets acceptance criteria.
- No information on sample sizes (test set, training set).
- No data provenance (country, retrospective/prospective).
- No number of experts, their qualifications, or adjudication methods for ground truth.
- No mention of MRMC comparative effectiveness or effect sizes.
- No indication of a standalone performance study.
- No type of ground truth used (pathology, outcomes, etc.) for any potential study.
- No information on how ground truth was established for a training set.

The document primarily focuses on:

Device description and intended use.
Technological characteristics and comparison to predicate devices for substantial equivalence.
Regulatory classifications and standards met.
FDA's clearance decision.

Therefore, I cannot generate the requested table or answer the specific questions about the study design and results from the provided input.

Summary

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510(K) Summary

This is a 510(K) summary in accordance with CFR807.82(c).

A. Submitter Information:

Submitter: Lightmed Corporation

NO.1-1, Lane1, Pao-An St. Sec. 3, Address: Shulin City, Taipei Hsien 23861, Taiwan

K091981

SEP 2 8 2009

Owner/Operator Number: Mr. Gary Lee, President / 9040850 Contact person: Anita Chen, Regulatory Affair TEL: +886-2-2688-1726 FAX: +886-2-2676-4920

B. Device Name:
Product Name: LightLas 577 Medical Optical Pumped Semiconductor Laser

Common name: Ophthalmic Laser, Surgical Laser

Classification name:

86 HQF, Laser, Ophthalmic

Regulation Number:

21 CFR 886.4390, Ophthalmic Laser

Regulatory Class: II

Performance standards: 21 CFR 1040.10 & 1040.11

C. Predicate Device Names:

(4) Device Names: LightLas 561 (K063297)

(5) Device Names: Novus Varia (K022181)

(6) Device Names: Family of IRIDEX IQ Laser System(K071687)

510K 577 A3

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D. Device Description:

The LightLas 577 Laser beam has a wavelength of 577mm, which is in the visible spectrum and is a Yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.

The LightLas 577 is a solid state, Optical Pumped Semiconductor surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 577nm.

Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

The intended use has not changed from the predicate devices.

E. Intended Use:

The LightLas 577 Medical Optical Pumped Semiconductor Laser is intended for use in ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

. Retinal Photocoagulation
Pan Retinal Photocoagulation .
Endophotocoagulation ●
Macular Photocoagulation
Laser Trabeculoplasty (to treat Open Angle Glaucoma)

The intended use has not changed from the predicate devices.

F. Technological Characteristics summary & Substantial Equivalence
The LightLas 577 Medical Optical Pumped Semiconductor Laser has the same indications for use as the Irides-IQ .577 (K071687). They have similar functional elements such as treatment wavelengths, pulse rates, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored in these systems for user intervention during a

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procedure or maintenance.

G. Performance Data Summary:

I cromance Bata Samilary.
The appropriate testing including safety, performance and functional testing to determine The appropriate testing methoding --------------------------------------------------------------------------------------------------------------------------------------------Laser System.

H. Conclusion

Conclusion equivalent to predicate devices currently legally marketed for the indication of retinal Cquivalent to "processes "abeculoplasty, the treatment of vascular and pigmented skin lessions, and other laser treatments.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 2 8 2009

Lightmed Corporation % Ms. Anita Chen No. 1-1, Lane 1, Pao-An St. Sec. 3 Shulin City, Taipei 23861 Taiwan

Re: K091981

Trade/Device Name: LightLas 577 Medical Optical Pumped Semiconductor Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Opthalmic laser Regulatory Class: Class II Product Code: HOF Dated: June 4, 2009 Received: July 1, 2009

Dear Ms. Chen:

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

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Page 2 - Ms. Anita Chen

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/CentersOffices/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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vandellay

For 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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14091981 510(K) Number (if Known):

Product / Trade Name: LightLas 577 Medical Optical Pumped Semiconductor Laser

Indications for Use:

Ophthalmology:

� Retinal Photocoagulation
Pan Retinal Photocoagulation
Endophotocoagulation .
Macular Treatments
Laser Trabeculoplasty

(7) The intended use has not changed from the predicate devices (K071687, K063297, K022181)

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

Concurrence of CDR, Office of Device Evaluation (ODE)

Prescription Use: _

OR Over-The-Counter Use:

(Per 21 CFR 801.109)

Nail RP Od formxm

Division of Surgical, Orthopedic, and Restorative Devices

: 10(k) Number K091981

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.