LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

K124043 · Lightmed Corp. · HQF · Sep 26, 2013 · Ophthalmic

Device Facts

• Record ID: K124043
• Device Name: LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
• Applicant: Lightmed Corp.
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LightLas577/670 Multi-Wavelength Medical Laser System is an ophthalmic laser 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.

Device Story

Ophthalmic laser system consisting of console, electronic control, power supplies, and laser delivery units (LDU). LDUs include slitlamp attachments (CSO SL980, SL990, Zeiss SL30), laser indirect ophthalmoscopes (Heine Omega 500, Keeler All pupil II), and endophotocoagulation handpieces. Operated by ophthalmologists in clinical settings. User selects wavelength (577nm or 670nm) and parameters via LCD touch screen. System software controls wavelength selection and output ports. Laser energy delivered to ocular tissue for photocoagulation or trabeculoplasty. Provides therapeutic benefit by treating retinal conditions and leaking vessels. Safety features include door interlocks, constant monitoring of safety systems, and displays for user intervention.

Clinical Evidence

Bench testing only. Evaluated per IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22, and ISO14971. Testing included assembly, calibration, and alignment of console and delivery units. Results confirmed compliance with specifications.

Technological Characteristics

Semiconductor/Diode laser; 577nm/670nm wavelengths; continuous wave and micro-pulse (10% duty cycle) modes; thermoelectric (Peltier) cooling; coaxial red laser diode aiming beam (635-650nm, max 1.0mW); 100-240 Vac power; Class IV laser safety.

Indications for Use

Indicated for ophthalmologists to perform retinal/pan-retinal photocoagulation, endophotocoagulation, macular photocoagulation for leaking vessels, and laser trabeculoplasty using 577nm or 670nm wavelengths.

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.

Predicate Devices

• LightLas532/670 (K103547)

Reference Devices

• CSO model SL980 (K992836)
• CSO model SL990 (K992836)
• Zeiss model SL30 (K862004)
• Heine Omega 500 (K123316)
• Keeler All pupil II (K854244)
• Endophotocoagulation Handpieces (K122905)

Submission Summary (Full Text)

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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 / 9040850<br>Contact person in Taiwan: Jocelyn Liu, Regulatory Affairs Officer | | | | | |
| | | | | | |
| | FAX: [phone] | | | | |
| | | | | | |

- 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 Corporation<br>LightLas532/670 | LightMed Corporation<br>LightLas577/670 |
|-------------------|-----------------------------------------|----------------------------------------------------------|
| 510K Number | K103547 | - |
| Lasing Medium | Frequency doubled<br>Nd:YAG/Diode | Semiconductor/Diode |
| Pulsing System | Continuous | Continuous |
| Output Wavelength | 532nm/670nm | 577nm/670nm |
| Micro Pulse | - | 10% Duty Cycle<br>(Power"On" 200μs,<br>Power"Off" 1800μs |

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| | | from 0.01s-Continuous<br>Wave 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 with<br>thermoelectric (Peltier)<br>heat pump | Solid State Cooling<br>with thermoelectric<br>(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

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.

- 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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