The Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

Retinal Photocoagulation .
Pan Retinal Photocoagulation
Endophotocoagulation
Macular Treatments
Laser Trabeculoplasty

Otolaryngology:

Stapedectomy
· Stapedotomy
· Myringotomy
· Lysis of adhesions
Control of bleeding
· Removal of acoustic neuromas ·
· Soft tissue adhesion in micro/macro otologic procedures.

Dermatology:

· Vascular lesion
· Pigmented lesion

The intended use has not changed from the predicate devices (K022327, K020071, K062369)

Device Description

The Medical Frequency Doubled YAG Laser is a solid state, frequency-doubled, green Nd: YAG surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532 retinal photocoagulator to allow use of the slit lamp to deliver 532 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

The provided text is a 510(k) summary for a medical device (Medical Frequency Doubled YAG Laser, Trade Name: LightLas 532). It focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert opinions, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document. The document explicitly states:

"The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Medical Frequency Doubled Y AG Laser System."
"The LightLas 532 is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation. laser trabeculoplasty. the treatment of vascular and pigmented skin lesions, and other laser treatments."

This indicates that the submission relies on demonstrating that the new device has "similar functional elements" and "same indications for use" as already cleared devices, and that it has undergone standard safety and functional testing, rather than an effectiveness study proving performance against specific quantitative acceptance criteria for accuracy, sensitivity, or specificity.

In summary, this document does not contain the information required to populate the table or answer the specific questions about acceptance criteria and study details.

Summary

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510(K) Summary

SEP 1 8 2009

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

A. Submitter Information:

Lightmed Corporation Submitter:

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

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: Medical Frequency Doubled YAG Laser Trade Name: LightLas 532

Trade Name: Digoxin 552

Common name: Ophthalmic Laser, Surgical Laser

Classification name:

86 HQF, Laser, Ophthalmic

79 GEX, Laser Powered Surgical Instrument

Regulation Number:

21 CFR 886.4390, Ophthalmic Laser

21 CFR 878-4810, Laser surgical instrument for use in general and plastic

surgery and in dermatology

Regulatory Class: II

Performance standards: 21 CFR 1040.10 & 1040.11

C. Predicate Device Names:

(1) Device Names: Novus Spectra Laser System (K022327)

(2) Device Names: Viridis Derma(K020071)

(3) Device Nambe: VariLite Laser System (K041930)

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D. Device Description:

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 Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

The intended use has not changed from the predicate devices.

Technological Characteristics summary & Substantial Equivalence F. The Medical Frequency Doubled YAG Laser has the same indications for use as the Irides-OcuLight TX (K062369). 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 procedure or maintenance.

G. Performance Data Summary:
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Medical Frequency Doubled Y AG Laser System.
H. Conclusion
The LightLas 532 is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation. laser trabeculoplasty. the treatment of vascular and pigmented skin lesions, and other laser treatments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

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

SEP 1 8 2009

Lightmed Corporation % Ms. Anita Chen Regulatory Affairs NO, 1-1, Lane 1, Pao-An St. Sec. 3 Shulin City, Tapei Hsien 23861 Taiwan

Re: K091534

Trade/Device Name: Medical Frequency Doubled YAG Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: August 24, 2009 Received: August 26, 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 avproval 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 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: registfation 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. Ànita 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,

Mark N. Milliman

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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1114162011 101 บอง มเลเบแนน เมเนเนเนเน บร มหมุนบอนบน บร

Kogi 534 510(K) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Product Name: Medical Frequency Doubled YAG Laser Trade Name: LightLas 532

Indications for Use:

Ophthalmology:

Retinal Photocoagulation .
Pan Retinal Photocoagulation
Endophotocoagulation
Macular Treatments
Laser Trabeculoplasty

Otolaryngology:

Stapedectomy
· Stapedotomy
· Myringotomy
· Lysis of adhesions
Control of bleeding
· Removal of acoustic neuromas ·
· Soft tissue adhesion in micro/macro otologic procedures.

Dermatology:

· Vascular lesion
· Pigmented lesion

The intended use has not changed from the predicate devices (K022327, K020071, K062369)

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

Concurrence of CDR, Office of Device Evaluation (ODE)

Prescription Use:	X OR Over-The-Counter Use:
(Per 21 CFR 801.109)

Med RE Ol for MXM

(Division Sign-Off)

Division of Surgical, Orthopedic,

and Restorative Devices

510K_ENT_A4.doc	66
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510(k) Number	K091534
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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.