VX650
Device Facts
| Record ID | K202221 |
|---|---|
| Device Name | VX650 |
| Applicant | Luneau Technology Operations |
| Product Code | HKI · Ophthalmic |
| Decision Date | Jan 29, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
Indications for Use
The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: - Measuring the refraction of the eye giving both lower and higher order aberrations - Measuring the shape of the cornea - Retro-illumination imaging of the eye - Measuring the intraocular pressure without contacting the eye for glaucoma evaluation - Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea - Full cornea thickness map - Scheimpflug imaging - Anterior chamber imaging - Pupil Image - Image of the cornea relative to the iris - Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent
Device Story
VX650 is a multi-function ophthalmic diagnostic platform; integrates wavefront aberrometer, corneal topographer, Scheimpflug pachymeter, non-contact tonometer, retro-illuminator, and non-mydriatic fundus camera. Input: ocular signals/images captured via automated alignment and focusing. Operation: wavefront aberrometer uses Shack-Hartmann principle; topographer uses Placido disk; pachymeter uses Scheimpflug slit-light imaging; tonometer uses air-puff; fundus camera uses IR-LED for alignment/focus and white LED flash for color retinal images. Output: refraction maps, corneal topography, intraocular pressure, corneal thickness, and retinal images. Used in clinical settings by eye care professionals. Output assists clinicians in cataract screening, glaucoma evaluation, and general ocular health assessment; benefits patient through comprehensive, single-platform diagnostic efficiency.
Clinical Evidence
Bench testing only. Compliance with ISO 14971, AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 15004-1/2, ISO 10940, IEC 62471, IEC 60825-1, ISO 10993-1, IEC 62366-1, IEC 60601-1-6, IEC 62304, ANSI Z80.36, ISO 8612, ISO 10342, ISO 10343, ISO 19980, and ISO 24157. Performance testing confirms device performs as intended without raising new safety or effectiveness questions.
Technological Characteristics
Multi-function diagnostic platform. Sensing: Shack-Hartmann (aberrometry), Placido disk (topography), Scheimpflug (pachymetry), air-puff (tonometry), CMOS sensor (fundus camera). Energy: LED-based (IR for alignment, white for flash). Connectivity: Standalone platform. Software: Moderate level of concern. Sterilization: N/A (non-contact).
Indications for Use
Indicated for patients requiring eye diagnostics including refraction, corneal topography, intraocular pressure measurement for glaucoma evaluation, corneal thickness evaluation, and non-mydriatic retinal imaging.
Regulatory Classification
Identification
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Special Controls
*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
January 29, 2021
Luneau Technology Operations Yossi Constantinis Group Regulatory Affairs & Ouality Manager 2 rue Roger Bonnet Pont-de-l'Arche, Rouen 27340 France
Re: K202221
Trade/Device Name: VX650 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX, HKI, MXK Dated: December 21, 2020 Received: December 28, 2020
Dear Yossi Constantinis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K202221
Device Name VX650
Indications for Use (Describe)
The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:
- · Measuring the refraction of the eye giving both lower and higher order aberrations
- · Measuring the shape of the cornea
- · Retro-illumination imaging of the eye
- Measuring the intraocular pressure without contacting the eye for glaucoma evaluation
- · Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea
- Full cornea thickness map
- · Scheimpflug imaging
- · Anterior chamber imaging
- · Pupil Image
- · Image of the cornea relative to the iris
- · Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# GENERAL INFORMATION:
| Company Name: | Luneau Technology Operations |
|----------------------------|------------------------------------------------------------------------------------------------------------------|
| Address | 2 rue Roger Bonnet,<br>27340 Pont-de-l'Arche - France |
| Phone: | +33232989132 |
| Primary contact<br>Person: | Yossi Constantinis<br>Group Regulatory Affairs<br>Email y.constantinis@luneautech.com<br>Phone: +972 546 535 299 |
| Second contact<br>Person: | Haggai Herman<br>General Manager<br>Email: h.herman@luneautech.com |
| Address: | 2 rue Roger Bonnet,<br>27340 Pont-de-l'Arche<br>France |
| Date Prepared: | August 3rd, 2020 |
# DEVICE IDENTIFICATION:
| Trade Name: | VX650 |
|----------------------|-----------------------|
| Generic Device Name: | Tonometer, Ac-Powered |
| Review Panel: | Ophthalmic |
| Classification: | Class II |
| Regulation Number: | 21 CFR 886.1930 |
| Product Code: | HKX |
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Image /page/4/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray circle with a blue and red stripe across it, followed by the text "Luneau Technology" in a bold, sans-serif font. Below the text, there are three smaller logos: VISIOONIX, briot, and WECO.
Subsequent product codes, based on other device functions in Class II:
HKI Camera, Ophthalmic, Ac-Powered
MXK Device, Analysis, Anterior Segment
# Device Description:
The VX650 is based on the VX130 (already cleared 510(k), number K162067) which is a combined wavefront aberrometer, corneal topographer, Scheimpflug pachymeter, non-contact tonometer and cataract screening device in a single platform that contains five different measurement units. The VX650 also contains a non-mydriatic fundus camera for retinal photography. The wavefront aberrometer uses the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye.
The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique, there is also a scanning mode that allows measurement of the whole corneal surface and can provide detailed tomography maps of both corneal surfaces and the corneal thickness.
An air puff non-contact tonometer is included for measurement of the intraocular pressure and retro illumination is present for cataract screening.
The fundus camera contains an infra-red LED for alignment and focusing and a white LED flash for the photography to give colour images. The fundus image covers an angle of 45° on the retina so a regular image will contain both the macula and the optic nerve. The fundus camera also has a seven-position fixation target to increase the field of view as the patient can fixate in different directions.
The device is fully automated and a number of different measurements can be performed by a sinqle command including alignment and focusing. The fundus imaging function is also fully automatic including automatic alignment, focusing and image capture.
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Image /page/5/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray circle with a blue, white, and red stripe across it, followed by the words "Luneau Technology" in bold, black font. Below that, in a smaller font, are the words "VISIXONIX briot WECO".
#### Indications For Use:
The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:
- Measuring the refraction of the eye giving both lower and higher order aberrations
- Measuring the shape of the cornea
- Retro-illumination imaging of the eye
- Measuring the intraocular pressure without contacting the eye for glaucoma evaluation
- Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea
- · Full cornea thickness map
- · Scheimpflug imaging
- · Anterior chamber imaging
- · Pupil Image
- Image of the cornea relative to the iris
• Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
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#### Identification of predicate devices:
The subject device is substantially equivalent to the following:
| Primary<br>predicate<br>Device | 510(k)<br>Holder | 510(k) no. | Date<br>cleared |
|--------------------------------|------------------|------------|-----------------|
| VX130 | Luneau | K162067 | 24 April 2017 |
The primary predicate refers to the one with indications for use and technological characteristics most similar to the subject device.
| Additional<br>predicate<br>devices related<br>to fundus<br>camera module | 510(k)<br>Holder | 510(k) no. | Date<br>cleared |
|--------------------------------------------------------------------------|------------------|------------|--------------------|
| Nexy | Next Sight | K180306 | 8 June 2018 |
| CenterVue Digital<br>Retinography<br>System DRS | CenterVue | K101935 | 27 October<br>2010 |
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#### Bench tests
As the predicate device VX130 (K162067), VX650 device complies with the following standards:
- ISO 14971 Third Edtion 2019-12 ●
- AAMI ANSI ES60601- 1:2005/(R)2012 And A1:2012 ●
- IEC 60601-1-2 Edition 4.0 2014-02 ●
- ISO 15004-1 First edition 2006-06-01 ●
- ISO 10940 Second edition 2009-08-01 ●
- IEC 62471 First edition 2006-07 ●
- IEC 60825-1 Edition 2.0 2007-03
- ISO 10993-1 Fourth edition 2009-10-15
- IEC 62366-1 Edition 1.0 2015-02 ●
- IEC 60601-1-6 Edition 3.1 2013-10 .
- IEC 62304 Edition 1.1 2015-06
- ANSI Z80.36-2016 American National Standard for Ophthalmics Light Hazard ● Protection for Ophthalmic Instruments
VX650 device complies also with the following standards:
- ISO 8612:2009 Ophthalmic instruments Tonometers .
- ISO 10342:2010 Ophthalmic instruments Eye refractometers ●
- ISO 10343:2014 Ophthalmic instruments Ophthalmometers ●
- ISO 19980:2012 Ophthalmic instruments Corneal topographers ●
- ISO 24157:2008Ophthalmic optics and instruments - Reporting aberrations of the human eye
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## Predicate Device comparison
Table 1 provides a comparison between the subject device and the primary predicate device.
| Table 1 - Predicate device comparison table with primary predicate device | | |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------|
| ATTRIBUTE /<br>CHARACTERISTICS | VX650<br>Subject Device | VX130<br>PD1 |
| Device Name | VX650 | VX130 |
| Comparison: Not Applicable | | |
| Device Manufacturer | Luneau | Luneau |
| Comparison: The device manufacturer is the same. | | |
| FDA Product Code | HKX<br>(main and primary code) | HKX |
| Comparison: Predicate device PD1 has the same FDA product code as subject device. | | |
| 510k reference | K202221 | K162067 |
| Comparison: Not Applicable | | |
| FDA Classification Name | Tonometer, Ac-Powered<br>(for the main and primary code) | Tonometer, Ac-Powered |
| Comparison: Predicate device PD1 has the same FDA Classification name of submitted product. | | |
| Classification | II | II |
| Comparison: Predicate device PD1 has the same FDA Classification as subject device. | | |
| FDA Regulation<br>Number | 886.1930<br>(according to main code) | 886.1930 |
| Comparison: Predicate device PD1 has the same regulation number of subject device. | | |
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=
| Table 1 - Predicate device comparison table with primary predicate device | | |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ATTRIBUTE /<br>CHARACTERISTICS | VX650<br>Subject Device | VX130<br>PD1 |
| | including fundus non-mydriatic camera | |
| | Comparison: Predicate device PD1 is a combination instrument including multi-function.<br>The subject device is a combination instrument including also (as an addition of predicate device PD1) a non-mydriatic fundus camera. | |
| Treatable areas | Eyes | Eyes |
| | Comparison: Predicate device PD1 has the same treatable areas as subject device. | |
| Alignment and<br>examination | Automatic - the device<br>automatically aligns to the<br>center of the pupil prior to<br>autofocusing and capture. | Automatic - the device<br>automatically aligns to the<br>center of the pupil prior to<br>autofocusing and capture. |
| | Comparison: Predicate device PD1 has the same alignment and examination procedure as the subject device. | |
| General Functionalities | The general functionalities of VX650 are:<br>Wavefront Keratometry Retro illumination Corneal topography Tonometry Pachymetry (single slit) Pachymetry (multi slit) Fundus photography | The general functionalities of VX130 are:<br>Wavefront Keratometry Retro illumination Corneal topography Tonometry Pachymetry (single slit) Pachymetry (multi slit) |
| | Comparison:<br>The subjected device has in addition the fundus photography, all the other functions are the same of predicate device PD1. | |
| Performance Standard<br>Compliance | Complies with the following standards:<br>IEC 60601-1:2005 IEC 60601-1-2:2014 ISO 10940-2:2009 ISO 60825-1:2014 ISO 62471-1:2006 ISO 8612:2010 ISO 10342:2010 ISO 24157:2008 ISO 19980:2012 ISO 10343-1:2014 ISO 15004-2 2007 ISO15004-1:2006 ISO 14971: 2012 ISO 62366:2007 ISO 62304: 2006 | Complies with the following standards:<br>IEC 60601-1:2005 IEC 60601-1-2:2014 ISO 60825-1:2014 ISO 62471-1:2006 ISO 8612:2010 ISO 10342:2010 ISO 24157:2008 ISO 19980:2012 ISO 10343-1:2014 ISO 15004-2 2007 ISO15004-1:2006 ISO 14971: 2012 ISO 62366:2007 ISO 62304: 2006 |
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Image /page/11/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray sphere with a blue and red stripe across it, followed by the text "Luneau Technology" in a sans-serif font. Below the text is the text "VISIONIX briot WECO" in a smaller font.
| Table 1 - Predicate device comparison table with primary predicate device | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------|
| ATTRIBUTE /<br>CHARACTERISTICS | VX650<br>Subject Device | VX130<br>PD1 |
| Comparison:<br>Subject device and predicate device PD1 comply with relevant standards, except for<br>ISO 10940-2:2009 that is applied specifically to VX650 since it includes fundus<br>camera module. | | |
Table 2 provides a comparison between the subject device additional predicate devices related to fundus camera module.
| Table 2 - Additional predicate devices related to fundus camera module | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| ATTRIBUTE /<br>CHARACTERISTICS | VX650<br>Subject Device | Nexy<br>Predicate Device PD2 | Digital Retinography<br>System DRS<br>Predicate Device PD3 |
| Device Name | VX650 | Nexy | Digital Retinography<br>System DRS |
| Comparison: Not Applicable | | | |
| Device<br>Manufacturer | Luneau | Next Sight srl | CenterVue |
| Comparison: Not Applicable | | | |
| FDA Product Code | HKX (main code);<br>subsequent codes for<br>class II functions are<br>HKI and MXK | HKI | HKI |
| Comparison: Both predicate devices PD2 and PD3 have product code identical to one of subsequent<br>code of subject device. | | | |
| 510k reference | K202221 | K180306 | K101935 |
| Comparison: Not Applicable | | | |
| FDA Classification<br>Name | Tonometer, Ac-Powered<br>(for the main code);<br><br>for the subsequent<br>codes:<br>HKI Camera,<br>Ophthalmic, Ac-Powered<br><br>MXK Device, Analysis,<br>Anterior Segment | Camera, Ophthalmic,<br>Ac-Powered | Camera, Ophthalmic,<br>Ac-Powered |
| Comparison: Both predicate devices PD2 and PD3 have the same FDA Classification name, that is the<br>same of one of the subsequent codes of the subject device (VX650). | | | |
| Classification | II | II | II |
| Comparison: Both predicate devices PD2 and PD3 have the same FDA Classification as subject<br>device. | | | |
| Type of device | Combination instument | Fundus non-mydriatic | Fundus non-mydriatic |
| ATTRIBUTE / CHARACTERISTICS | VX650 Subject Device | Nexy Predicate Device PD2 | Digital Retinography System DRS Predicate Device PD3 |
| | including fundus non-mydriatic camera | camera | camera |
| Comparison: Both predicate devices PD2 and PD3 are non-mydriatic fundus cameras. The subject device is a combination instrument including a non-mydriatic fundus camera module. | | | |
| Treatable areas | Eyes | Eyes | Eyes |
| Comparison: Both predicate devices PD2 and PD3 have the same treatable areas as subject device | | | |
| Alignment and examination | Automatic - the device automatically aligns to the center of the pupil prior to autofocusing and capture. | Automatic - the device automatically aligns to the center of the pupil prior to autofocusing and capture. | Automatic - the DRS device automatically aligns to the center of the pupil prior to autofocusing and capture. |
| Comparison: Both predicate devices PD2 and PD3 have the same alignment and examination procedure as the subject device. | | | |
| Field of horizontal vision | 45° | 45° | 45° |
| Field of vertical vision | 45° | 45° | 40° |
| Comparison:<br>Field of view represents the portion of the field of vision of the retina that can be framed with the device. The predicate device PD2 has the same field of view as the subject device. The field of horizontal vision of the predicate device PD3 is the same as the subject device but the vertical field is 5° smaller.<br>Regarding the field of vertical vision, a difference of 5º degrees does not bring a point of non-substantial equivalence between the VX650 device and a predicate device, as it does not influence the intended use, the performance, the safety and effectiveness of the system. | | | |
| Minimum pupil size | 3.5mm | 3.8mm | 4mm |
| Comparison:<br>The minimum pupil size parameter represents the size of the smallest pupil that can be measured. Both predicate devices PD2 and PD3 have slightly larger minimum pupil sizes than the subject device. It does not bring a point of non-substantial equivalence between the submitted device and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system. | | | |
| Image sensor | CMOS | CMOS | CMOS |
| Comparison: Both predicate devices PD2 and PD3 have the same image sensor type as the subject device. | | | |
| Sensor size | 6 M pixel | 2.1 M pixel | 5 M pixel |
| Comparison:<br>Predicate device PD3 has a similar sensor resolution as the subject device. The sensor resolution of the predicate device PD2 is smaller than the subject device, the subject device therefore is slightly better. | | | |
| Table 2 - Additional predicate devices related to fundus camera module | | | |
| ATTRIBUTE /<br>CHARACTERISTICS | VX650<br>Subject Device | Nexy<br>Predicate Device PD2 | Digital Retinography<br>System DRS<br>Predicate Device PD3 |
| retina | | | |
| Comparison: The subject device has better fundus resolution than the predicate devices. | | | |
| Light source | LEDs | LEDs | LEDs |
| Comparison: Both predicate devices PD12 and PD3 have the same light source as subject device. | | | |
| Type of fixation<br>light | Blue and continuous<br>(during the exam time)…
