LightLas 577/670 is an ophthalmic laser instrument intended for use by ophthalmologists. The 577 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation. endophotocoagulation, macular photocoagulation to treat leaking vessels. and laser trabeculoplasty. The 670 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation.

Device Description

LightLas577/670 Multi-Wavelength Medical Laser System consists of a Laser Console where the Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include: Slitlamp Integrated into CSO model SL980. (K992836) . Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. . Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ● . Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0 . Endophotocoagulation Handpieces (K122905) The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.

AI/ML Overview

The provided text describes a 510(k) summary for the LightLas577/670 Multi-Wavelength Medical Laser System. This document focuses on demonstrating substantial equivalence to a predicate device through technical comparison and compliance with recognized standards. It does not contain information about clinical studies with acceptance criteria or reported device performance in those terms.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.

However, based on the provided text, here's what I can extract regarding the study information (or lack thereof):

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not describe specific acceptance criteria tied to clinical performance metrics (e.g., sensitivity, specificity, accuracy) or present reported device performance against such criteria. The "Performance Data" section indicates compliance with recognized standards (IEC, ISO) and successful bench testing, which are engineering/safety criteria, not clinical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance:

No information provided. The document does not refer to a "test set" in the context of clinical data, nor does it mention sample sizes or data provenance (country of origin, retrospective/prospective). The "test results" mentioned refer to bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

No information provided. Since no clinical test set is described, there's no mention of experts or expert consensus for ground truth.

4. Adjudication Method:

No information provided. No clinical test set means no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done or reported. The document does not mention any studies involving human readers, AI assistance, or comparative effectiveness.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a laser system, not an AI algorithm. "Standalone performance" as typically applied to algorithms is not relevant here.

7. Type of Ground Truth Used:

Not applicable. For the bench testing mentioned, ground truth would be established by validated measurement equipment and engineering standards, not clinical outcomes or pathology.

8. Sample Size for the Training Set:

Not applicable. This device is a laser system and does not involve AI models that require training sets.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, no training set for an AI model.

Summary of Device Evaluation from the Text:

The device's safety and effectiveness were evaluated through:

Bench testing: This involved assembly, testing, calibration, and alignment of the laser console and delivery units. The results demonstrated compliance with specifications and requirements.
Compliance with recognized consensus standards: IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22, and ISO14971.

The conclusion drawn from this evaluation was that the "LightLas 577/670 Multi-Wavelength Medical Laser System demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device." This statement refers to demonstrating substantial equivalence to the predicate device (K103547) based on technical characteristics, intended use, and compliance with general safety and performance standards for ophthalmic lasers, rather than presenting a clinical study with performance metrics against acceptance criteria.

Summary

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Section 11 510(k) Summary or Statement

510(K) Summary .

ﺬ

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

	Submitter Information:
	Submitter:	LightMed Corporation
	Address:	NO.1-1, Lane1, Pao-An St. Sec. 3,
		Shulin Dist., New Taipei City 23861, Taiwan
Owner/ Operation Number: Mr. Gary Lee, President / 9040850Contact person in Taiwan: Jocelyn Liu, Regulatory Affairs Officer

	FAX: +886-2-2676-4920

Device Name B.
Product Name: LightLas577/670 Multi-Wavelength Medical Laser System Common Name: Ophthalmic Laser, Surgical Laser Classification Name: 86 HQF, Laser, Ophthalmic

Regulation Name: 21 CFR 886.4390, Ophthalmic Laser Regulatory Class: II Performance standards: 21 CFR 1040.10 & 1040.11

C. Device Technological Characteristics to Predicate Device:

Manufacturer	LightMed CorporationLightLas532/670	LightMed CorporationLightLas577/670
510K Number	K103547	-
Lasing Medium	Frequency doubledNd:YAG/Diode	Semiconductor/Diode
Pulsing System	Continuous	Continuous
Output Wavelength	532nm/670nm	577nm/670nm
Micro Pulse	-	10% Duty Cycle(Power"On" 200μs,Power"Off" 1800μs

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		from 0.01s-ContinuousWave for 577 nm only
Average Power(AP)	2W/0.7W	2W/0.7W
Laser Safety Class	4/IV	4/IV
Exposure Sections (t)	0.01s to continuous	0.01s to continuous
Cooling Method	Solid State Cooling withthermoelectric (Peltier)heat pump	Solid State Coolingwith thermoelectric(Peltier) heat pump
Aiming Beam:	Coaxial with treatment beam
Aiming Beam: Type	Red Laser Diode	Red Laser Diode
Aiming Beam: Wavelength	635-650nm (Red)	635-650nm (Red)
Aiming Laser power	Maximum of 1.0mW	Maximum of 1.0mW
Laser Safety Class	2/II	2/II
Power requirements: Voltage	100 to 240 Vac	100 to 240 Vac

D. Device Description

The LDU's include:

Slitlamp Integrated into CSO model SL980. (K992836) .
Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. .
Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) .
Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ●
Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0
. Endophotocoagulation Handpieces (K122905)

The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.

E. Intended Use:
LightLas577/670 Multi-Wavelength Medical Laser System is an ophthalmic laser

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instrument intended for use by ophthalmologists. The 577 nm wavelength laser is indicated for retinal and pan-retinal photocoagulation, endophotocoagulation, macular photocoagulation to treat leaking vessels, and laser trabeculoplasty. The 670 nm wavelength laser is indicated for retinal and pan-retinal photocoagulation. The intended use has not changed from the predicate device (K103547)

Substantial Equivalence F.

LightLas577/670 Multi-Wavelength Medical Laser System has the same intend use, general design and fundamental scientific technology as the predicate device (K103547) Also the operating controls and functions are equivalent to the product. They have the same functional elements such as treatment wavelengths, 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.

The difference in specifications of LightLas577/670 and LightLas532/670 (K103547) is that LightLas577/670 is based upon LightLas532/670 (K103547) with a modification of laser sources and corresponded control boards which causes different laser outputs. LightMed Corporation has demonstrated by evaluation of LightLas577/670 that modifications to current predicate devices are effective and safe.

There are no new hazards introduced by the Laser System as compared with the predicate devices.

Performance Data: ও

LightLas577/670 Multi-Wavelength Medical Laser System was evaluated according to the requirements of FDA recognized consensus standards (IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22 and ISO14971).These tests and evaluations were performed at LightMed facility and at outside test facilities as required.

Bench testing performance was completed, including the assembly, testing calibration and alignment of LightLasS77/670 laser console and laser delivery units. demonstrated that performance of LightLas577/670 test results All Multi-Wavelength Medical Laser System complies with specifications and requirements.

The conclusions drawn from the performance testing of the LightLas 577/670 Multi-Wavelength Medical Laser System demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

September 26, 2013

Lightmed Corporation Ms. Jocelyn Liu Regulatory Affairs Coordinator No. 1-1. Lane 1. Pao-An St. Sec. 3. Shulin District, New Taipei City 23861, Taiwan

Re: K124043

Trade/Device Name: LightLas 577/670 Multi-Wavelength Medical Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 16, 2013 Received: August 23, 2013

Dear Ms. Liu:

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 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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Deborah Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement as Requested by FDA

510(K) Number (if Known): Product Name: LightLas577/670 Multi-Wavelength Medical Laser System Trade Name: LightLas 577/670

Indications for Use:

The intended use has not changed from the predicate devices (K103547)

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

Concurrence of CDR, Office of Device Evaluation (ODE)

Prescription Use: __ X (Per 21 CFR 801.109)

OR Over-The-Counter Use:

Charles Chilano 2013.09 26 14:53

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K124043

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.