LightLas Multi-Wavelength Medical Laser System

K152688 · Lightmed Corporation · HQF · Jun 15, 2016 · Ophthalmic

Device Facts

• Record ID: K152688
• Device Name: LightLas Multi-Wavelength Medical Laser System
• Applicant: Lightmed Corporation
• Product Code: HQF · Ophthalmic
• Decision Date: Jun 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for: · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp

Device Story

LightLas 532/810 is a multi-wavelength ophthalmic laser system; emits 532 nm (frequency-doubled Nd:YAG) and 810 nm (diode) laser beams. Used by ophthalmologists in clinical settings for retinal and glaucoma procedures. System includes laser console, LCD touch panel, ophthalmic table, slitlamp, and endolaser probes. User selects wavelength and output port via touch screen; software controls laser delivery. Device provides therapeutic photocoagulation or trabeculoplasty to treat ocular conditions; benefits include targeted tissue treatment for retinal and glaucoma pathologies. Output is delivered via slitlamp or endoprobe to the patient's eye.

Clinical Evidence

Bench testing only. Includes finished product quality inspection, system calibration, electrical safety, and EMC testing. Software verification and validation performed per FDA guidance for major level of concern software.

Technological Characteristics

Multi-wavelength laser (532 nm diode-pumped frequency-doubled Nd:YAG; 810 nm diode). Solid-state thermoelectric (Peltier) cooling. Class 4 laser system. Aiming beam: 635-650 nm red laser diode (Class 2). Connectivity: LCD touch panel interface. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, 21 CFR 1040.10, 21 CFR 1040.11.

Indications for Use

Indicated for ophthalmologists to treat ocular pathologies including proliferative diabetic retinopathy, retinal tears/detachments, clinically significant macular edema (CSME), choroidal neovascularization (CNV) associated with wet age-related macular degeneration, and primary open angle glaucoma (POAG).

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

• Quantel Medical Supra Twin (K081946)
• LightMed Corporation LightLas 532/670 (K103547)

Reference Devices

• CSO Slitlamp SL980 (K992836)
• Endolaser probe (K133019)

Submission Summary (Full Text)

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

June 15, 2016

Lightmed Corporation % Ms. Mollie Li Regulatory Affairs Administrator No. 1-1. Lane 1. Pao-An St., Sec 3. Shulin Dist New Taipei City, 23861 TW

Re: K152688

Trade/Device Name: Lightlas Multi-wavelength Medical Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: May 16, 2016 Received: May 18, 2016

Dear Ms. Li:

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.

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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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

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

510(k) Number (if known) K152688

Device Name Lightlas 532/810

| Indications for Use (Describe) | |
|--------------------------------|--|
|--------------------------------|--|

- LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for:
- · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
- · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
- · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
- Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet
- age-related macular degeneration (wet AMD)- with Slitlamp
- · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

This is 510(K) summery in accordance with 21 CFR 807.92.

#### I. SUBMITTER

LightMed Corporation No1-1, Ln1, Sec. 3, Pao An St., Shulin Dist., New Taipei City 23861, Taiwan, R.O.C. TEL: [phone] FAX: [phone] Establishment registration number: 3008156177 Contact person: Mollie Li, Regulatory Affairs Coordinator Daniel Shih, Regulatory Compliance Engineer Anderson Lin/ Business Development Administrator (USA office phone no: [phone] Ext. 103) Summary Preparation Date: May 16th 2016

# II. DEVICE

Trade name: LightLas 532/810 The common name of the device: Laser Instrument, surgical, powered & Laser, ophthalmic The classification name: 21 CFR 886.4390, Class II Product code: HQF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11

#### III. PREDICATE DEVICE

Quantel Medical Supra Twin (K081946) LightMed Corporation LightLas 532/670 (K103547) The predicate devices have not been subject to a design-related recall.

#### IV. DEVICE DESCRIPTION

LightLas 532/810 Multi-Wavelength Medical Laser System can emit 532 nm wavelength laser beam and 810 nm wavelength laser beam. The 532 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 810 nm 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.

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LightLas 532/810 Multi-Wavelength Medical Laser System is intended for use by ophthalmologists for treatment of ocular pathology, and the system consists of the following functional components:

- LCD touch panel ●
- Laser Console
- Ophthalmic Instrument table ●
- CSO Slitlamp SL980 (K992836) ●
- Endolaser probe (K133019)

# V. INDICATIONS FOR USE

LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for:

- . Pan-retinal photocoagulation for proliferative diabetic retinopathy - with Slitlamp or Endoprobe
- . Laser retinopexy for retinal tear and detachments - with Slitlamp or Endoprobe
- . Focal or grid photocoagulation for clinically significant macular edema (CSME) with Slitlamp
- . Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD) – with Slitlamp
- Trabeculoplasty for primary open angle glaucoma (POAG) with Slitlamp .

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Model Name | LightLas532/810 | Supra Twin<br>(Primary predicate<br>device) | LightLas 532/670 | | |
|-----------------------|--------------------------------------------|---------------------------------------------|----------------------|--|--|
| Manufacturer | LightMed Corporation | Quantel Medical | LightMed Corporation | | |
| 510K Number | | K081946 | K103547 | | |
| Treatment Laser | | | | | |
| | 532 nm (Green) | 532 nm (Green) | 532 nm (Green) | | |
| Wavelength | 810 nm (Infrared) | 810 nm (Infrared) | 670 nm (Red) | | |
| | 532 nm: | 532 nm: | 532 nm: | | |
| Laser type | Diode-pumped | Diode-pumped | Diode-pumped | | |
| | Frequency Doubled | Frequency Doubled | Frequency Doubled | | |
| | Nd:YAG Laser | Nd:YAG Laser | Nd:YAG Laser | | |
| | 810 nm: Diode Laser | 810 nm: Diode Laser | 670 nm: Diode Laser | | |
| Power Output | 532 nm: 50mW ~ | 532 nm: 30mW ~ | 532 nm: 50mW ~ | | |
| | 2000mW | 3000mW | 2000mW | | |
| | 810 nm: 50mW ~ | 810 nm: 30mW ~ | 670 nm: 50mW ~ | | |
| | 3000mW | 3000mW | 700mW | | |
| Laser Safety<br>Class | 4/IV | 4/IV | 4/IV | | |
| Exposure Time | 0.01s to continuous | 0.01s to continuous | 0.01s to continuous | | |
| | Solid State Cooling | Solid State Cooling | Solid State Cooling | | |
| Cooling Method | with thermoelectric | with thermoelectric | with thermoelectric | | |
| | (Peltier) heat pump<br>(Peltier) heat pump | | (Peltier) heat pump | | |
| Aiming Beam | | | | | |
| Type | Red Laser Diode | Red Laser Diode | Red Laser Diode | | |
| Wavelength | 635-650nm (Red) | 635-650nm (Red) | 635-650nm (Red) | | |
| Laser power | Maximum of 1.0mW | Maximum of 1.0mW | Maximum of 1.0mW | | |
| Laser Safety | | | | | |
| Class | 2/II | 2/II | 2/II | | |
| Others | | | | | |
| Power | | | | | |
| requirements: | 100 to 230 Vac | 100 to 240 Vac<br>100 to 230 Vac | | | |
| Voltage | | | | | |

The Indications for Use statement for LightLas532/810 is not identical to the

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predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The performance data to account for the differences listed in the table are provided in Section VII of this summary below.

# VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Bench Testing

Bench Testing were completed including the Finished Product final assembly quality Inspection, System Adjustment, Calibration and Testing for Laser console of LightLas 532/810 Laser System.

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LightLas 532/810 device, consisting of the laser console and TruScan module integrated Slitlamp. The system complies with the IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.

## Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

## VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LightLas 532/810 Laser System should perform as intended in the specified use conditions. The clinical evaluation data demonstrate that LightLas 532/810 Laser System performs comparably to the predicate devices which are currently marketed for the same intended use.