Eyer 2

K251353 · Phelcom Technologies · HKI · Jan 16, 2026 · Ophthalmic

Device Facts

• Record ID: K251353
• Device Name: Eyer 2
• Applicant: Phelcom Technologies
• Product Code: HKI · Ophthalmic
• Decision Date: Jan 16, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Eyer 2® is a portable fundus camera for use with the Samsung Galaxy S21, Galaxy S22, or Galaxy S23 smartphone to capture fundus images. It can be coupled to a front module for imaging of the surface of the eye and the surrounding areas, including the meibomian glands.

Device Story

Eyer 2 is a portable, smartphone-based ophthalmic camera (Samsung Galaxy S21/S22/S23) for non-mydriatic fundus imaging and ocular surface/meibomian gland imaging. Device uses infrared light for targeting and white/blue light for image capture. It features an ocular surface module for non-contact imaging. Captured images/videos are stored in an internal smartphone application database and can be transferred via DICOM, DICOMWEB, FTPS, or local folders. Operated by healthcare professionals in clinical settings, the device provides visual documentation to assist in clinical decision-making and patient monitoring. The system automatically generates infrared, color, and green-channel fundus images during the capture workflow. Benefits include portable, high-resolution imaging for ophthalmic assessment without requiring mydriasis in most cases.

Clinical Evidence

Bench testing only. Performance verified through electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), optical safety (ANSI Z80.36), and optical performance (ISO 10940). Biocompatibility of patient-contacting silicone components confirmed per ISO 10993 and USP Class IV. Software verification and validation conducted per IEC 62304 (Class A).

Technological Characteristics

Portable ophthalmic camera using Samsung Galaxy S21/S22/S23 smartphones. Illumination: White, NIR, and Blue LEDs. Diopter compensation: -20D to +20D. Connectivity: DICOM, DICOMWEB, FTPS. Biocompatible silicone eye cap (SILPURAN 2420). Standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ANSI Z80.36, ISO 10940, ISO 10993. Software class: IEC 62304 Class A.

Indications for Use

Indicated for use by healthcare professionals in a medical environment to capture, document, and consult on images and videos of the fundus, ocular surface, and surrounding areas (including meibomian glands). Not patient population specific.

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

• Eyer Retinal Camera NM-STD (K221329)
• Optomed Aurora Camera (K180378)

Reference Devices

• LipiView II Ocular Surface Interferometer (K152869)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 16, 2026

Phelcom Technologies
José Roberto Santiciolli Filho
R&D Manager
Rua José Missali, 820, Pq Santa Felícia
São Carlos, São Paulo 13562-405
Brazil

Re: K251353
Trade/Device Name: Eyer 2
Regulation Number: 21 CFR 886.1120
Regulation Name: Ophthalmic Camera
Regulatory Class: Class II
Product Code: HKI
Dated: December 8, 2025
Received: December 8, 2025

Dear José Roberto Santiciolli Filho:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251353 - José Roberto Santiciolli Filho
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251353 - José Roberto Santiciolli Filho
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# BRADLEY S. CUNNINGHAM -S

CAPT Brad Cunningham, MSE, RAC
Acting 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251353 | |
| Device Name Eyer 2 | |
| Indications for Use (Describe) Eyer 2® is a portable fundus camera for use with the Samsung Galaxy S21, Galaxy S22, or Galaxy S23 smartphone to capture fundus images. It can be coupled to a front module for imaging of the surface of the eye and the surrounding areas, , including the meibomian glands. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K251353
PHELCOM
E
P H E L C O M

# 510 (k) Summary

510(k) submitter: Phelcom Technologies S/A
820, José Missali St., Santa Felícia District. São Carlos - SP - Brazil. ZIP Code: 13562-405
Company phone: [phone]
Contact person: José Roberto Santiciolli Filho
Date: January, 14, 2026

Subjective device:
Trade name: Eyer 2
510 (k) number: K251353
Common/usual name: Ophthalmic camera
Classification name: camera, ophthalmic, ac-powered (21 CFR 886.1120)
Regulatory Class: II
Product Code: HKI

Predicate Device #1:
Trade name: Eyer Retinal Camera NM-STD
510 (k) number: K221329
Regulatory Class: II
Product Code: HKI

Predicate Device #2:
Trade name: Optomed Aurora Camera
Optomed Aurora Retinal Module
Optomed Aurora Anterior Module

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PHELCOM TECHNOLOGIES
Traditional 510(k) Premarket Submission
Eyer 2
K251353
P H E L C O M

510 (k) number: K180378
Regulatory Class: II
Product Code: HKI

Reference Device #1:
Trade name: LipiView II Ocular Surface Interferometer
510 (k) number: K152869
Regulatory Class: II
Product Code: HKI

# 1. Description of the device

The Eyer 2 is accompanied by accessories: frontal module for the ocular surface (1pc), dock station (charging station) (1pc), eye cap (1pc), lens protector (1 pc), storage case (1 pc), cleaning cloth (1 pc), allen wrench (1 pc), quick start guide (1 pc), welcome card (1 pc), shipping box (1 pc), power supply (1 pc), slit-lamp adapter (1 pc), silica gel bags (2 pcs).

Eyer 2 is designed for use in a medical environment by healthcare professionals. Captured images and videos are used for documentation and consultation. The images and videos are securely stored in an internal smartphone application database.

For the retinal function, the Eyer 2 is designed for non-mydriatic fundus imaging. In non-mydriatic imaging, no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Eyer 2 has fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the optical disc in the center by selecting the appropriate point.

For the ocular surface and surrounding areas function, Eyer 2 has an ocular surface module with white, blue, and infrared light sources for imaging the eye surface and surrounding areas; in this configuration, the device does not make contact with the patient.

The transfer of images to a PC is carried out via DICOM, DICOMWEB, FTPS, or local folder connections, with the client responsible for the connection and subsequent storage.

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PHELCOM TECHNOLOGIES
Traditional 510(k) Premarket Submission
Eyer 2
K251353
P H E L C O M

The Eyer 2 energy comes from the smartphone that has a rechargeable Li-Ion battery and is charged when the device is docked on the charge station, which is connected to the mains by a power supply cable.

2. Indications for Use

Eyer 2® is a portable fundus camera for use with the Samsung Galaxy S21, Galaxy S22, or Galaxy S23 smartphone to capture fundus images. It can be coupled to a front module for imaging of the surface of the eye and the surrounding areas, including the meibomian glands.

3. Contraindications

There are no known contraindications.

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K251353

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

# 4. Comparison of Technological Characteristics

Table 4A below includes a summary of the technical information used in the substantial equivalence discussion.

# 4A- Comparison of Characteristics

| Characteristic | Subject Device | Predicate Device #1 | Predicate Device #2 | Reference Device #1 |
| --- | --- | --- | --- | --- |
| Regulatory Information | | | | |
| Device Name | Eyer 2 | Eyer Retinal Camera | Optomed Aurora Camera
Optomed Aurora Retinal Module
Optomed Aurora Anterior Module | LipiView II Ocular Surface Interferometer |
| Manufacturer | Phelcom Technologies | Phelcom Technologies | Optomed | Tear Science |
| 510(k) Number | K251353 | K221329 | K180378 | K152869 |
| Product Code | HKI | HKI | HKI | HKI |
| Device Class
CFR Section
Common Name | Class II
21 CFR 886.1120
Ophthalmic camera | Class II
21 CFR 886.1120
Ophthalmic camera | Class II
21 CFR 886.1120
Ophthalmic camera | Class II
21 CFR 886.1120
Ophthalmic camera
and
21 CFR 886.1850
AC-powered slit lamp biomicroscope |

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K251353

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

| Indications for Use | Eyer 2® is a portable fundus camera for use with the Samsung Galaxy S21, Galaxy S22, or Galaxy S23 smartphone to capture fundus images. It can be coupled to a front module for imaging of the surface of the eye and the surrounding areas, including the meibomian glands. | Eyer Retinal Camera is a medical digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the fundus of the human eye, surface of the human eye, and surrounding areas. | Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and videos of the fundus of the eye and surface of the eye.
Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.
Optomed Aurora Camera with Anterior Module is intended to capture digital images and videos of the surface of the human eye and surrounding areas. | The LipiView II Ocular Surface Interferometer is an ophthalmic imaging device intended for use by a physician in adult patient to capture, archive, manipulate and store digital images of:
• Specular (interferometric) observations of the tear film. Using these images, LipiView® II measures the absolute thickness of the tear film lipid layer.
• Meibomian glands under near-infrared (NIR) illumination
• The ocular surface and eyelids under with illumination |
| --- | --- | --- | --- | --- |
| Usage | Prescription use. | Prescription use. | Prescription use. | Prescription use. |
| Use Condition | Intended to be used without mydriasis but can be used also with mydriatic drops. | Intended to be used without mydriasis but can be used also with mydriatic drops. | Intended to be used without mydriasis but can be used also with mydriatic drops. | Intended to be used without mydriasis. |
| Target Population | The images/ system is not patient population specific. | The images/ system is not patient population specific. | The images/ system is not patient population specific. | Adult patients. |

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K251353

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

| Hardware Design Features | | | | |
| --- | --- | --- | --- | --- |
| Illumination source | Eyer 2
White: Lumileds L1RX-576000000000; NIR: OSRAM SFH 4053; Target: Display Winstar WEO006448AWPP3N00000
Ocular Surface Module:
White: Lumileds L1RX-576000000000; NIR: Lumileds L1IZ-0940000000000; Blue: Lumileds LXz1-PB01 | Eyer Retinal Camera
White: OSRAM Oslon Compact, LUW CEUP.CE; NIR: OSRAM SFH 4053; Target LEDs: Kingbright, APG0603 SRC-TT | Aurora Retinal Module:
White: OSRAM Oslon LUW-H9GP; NIR: OSRAM Oslon SFH-4716; Target LEDs: Vishay VLMS1500-GS08.
Aurora Anterior Module:
White: OSRAM Advanced Power Topled LW G6SP-EAFS-JKQL-1
Blue: OSRAM Advanced Power Topled LB G6SP-V2BB-35-1 | LipiView II Interferometer:
Visible White Class I LED illumination;
Visible LED fixation light;
Near-Infrared LED illumination and transillumination of the eyelid. |
| Display system | 6.2", 1080 x 2400 pixels, Gorilla Glass protection (Smartphone Samsung Galaxy S21);
6.1", 1008x2340 pixels, Gorilla Glass protection (Smartphone Samsung Galaxy S22);
6.1", 1008x2340 pixels, Gorilla Glass protection (Smartphone Samsung Galaxy S23). | 6.1", 1400x3040 pixels, Gorilla Glass protection (Smartphone Samsung Galaxy S10). | 4.0", TFT-LCD, 800x480 pixels, 16.7 M colors, anti-glare coating. | Touchscreen display to view images; |

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K251353

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

| Camera sensor specification | Color CMOS camera maximum resolution 12 Mp (Smartphone Samsung Galaxy S21).
Color CMOS camera maximum resolution 50 Mp (Smartphone Samsung Galaxy S22).
Color CMOS camera maximum resolution 50 Mp (Smartphone Samsung Galaxy S23). | Color CMOS camera maximum resolution 12 Mp (Smartphone Samsung Galaxy S10). | Color CMOS maximum resolution 5Mp. | Does not publicly disclose detailed technical specifications of camera sensors. |
| --- | --- | --- | --- | --- |
| Diopter compensation | From -20D to +20D | From -20D to +20D. | From -20D to +20D. | - |
| Field of view | 55x45 degrees | 45 degrees. | 50x40 degrees. | - |
| Storage media | Internal smartphone storage. | Internal smartphone storage. | MicroSDHC memory card. | Store images on computer and external media |
| Image data format | JPEG, MPEG-4. | JPEG, MPEG-4. | JPEG, MPEG-4. | JPEG, MPEG-4. |
| Weight | Eyer 2: 703 g
Ocular Surface Front Module: 137 g | Eyer Retinal Camera: 700 g | Aurora Camera: 514 g;
Aurora Retinal Module: 310 g;
Aurora Anterior Module: 105 g. | 5 - 10 kg. |

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K251353

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

| Battery | Rechargeable Li-Ion battery, 3.85V, 4000 mAh (Smartphone Samsung Galaxy S21).
Rechargeable Li-Ion battery, 3.85V, 3700 mAh (Smartphone Samsung Galaxy S22).
Rechargeable Li-Ion battery, 3.85V, 3900 mAh (Smartphone Samsung Galaxy S23). | Rechargeable Li-Ion battery, 3.85V, 3400 mAh (Smartphone Samsung Galaxy S10). | Rechargeable Li-Ion battery, 5000065, 3.63V, 2600mAh. | AC- powered. |
| --- | --- | --- | --- | --- |
| Output terminal and data collection | Media transfer via DICOM, DICOMWEB, FTPS or local folders connections | Media transfer via FTP, DICOM, and CIFS communication. | USB(1.1) terminal (B-connector).
Compatible with Windows® 7/8/10 and macOS (three latest versions). | Support for off-the-shelf USB printers and media that are compatible with Windows 7 and USB 2.0. |
| Standards | • IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2);
• IEC 60601-1-2:2014 (edition 4.0);
• ISO 15004-1:2020;
• ANSI Z80.36:2021;
• ISO 10940:2009
• NEMA | • IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2);
• IEC 60601-1-2:2014 (edition 4.0);
• ISO 15004-1:2020;
• ANSI Z80.36:2016;
• ISO 10940:2009
• NEMA
PS3.1-30.20:2021; | • IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2);
• IEC 60601-1-2:2014 (edition 4.0);
• IEC 60601-6:2010 + A1:2013 (edition 3.1);
• IEC 62741:2006;
• ISO 15004-1:2006;
• ISO 15004-2:2007; | • IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2);
• IEC 60601-1-2:2017 (edition 3.0);
• ISO 15004-1:2006;
• ISO 15004-2:2007; |

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K251353

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

| | PS3.1-30.20:2023e;
• IEC 62304:2015;
• ISO 10993-1:2018;
• ISO 10993-5:2009;
• ISO 10993-10:2010. | • IEC 62304:2015;
• ISO 10993-1:2018;
• ISO 10993-5:2009;
• ISO 10993-10:2010. | • ISO 10940:2009;
• ISO 10993-5:2009;
• IEC 62304:2006+A1:2015;
• IEC 62366-1:2015. | |
| --- | --- | --- | --- | --- |

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PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

K251353

P H E L C O M

# 5. Discussion of differences

The Eyer 2 does have a significant difference between your predicates and reference device.

The following items are the differences between the devices:

- Exams

The Eyer 2 combines most of the imaging functions present across all predicate and reference devices, offering color fundus photography, green channel fundus photography, infrared fundus photography, ocular surface imaging color and with blue excitation, and meibomian gland imaging under near-infrared illumination. One exception is the interferometry function of the LipiView II, which measures the lipid layer thickness of the tear film and is not included in the Eyer 2.

The Eyer 2 performs color fundus photography and is capable of generating digital green channel image, equivalent to those of the Eyer Retinal Camera, as shown in the images below:

Eyer 2 color exam

Eyer Retinal Camera color exam

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K251353

PHELCOM

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

Eyer 2 digital green channel fundus

Eyer Retinal Camera green channel fundus

The Eyer 2 performs white and blue light examinations of the surface of the eye and the surrounding areas, equivalent to those of the Optomed Aurora Camera with Optomed Aurora Anterior Segment, as shown in the images below.

Eyer 2 with Ocular Surface Module with white excitation.

Optomed Aurora Camera with Optomed Aurora Anterior Module with white excitation.

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K251353

PHELCOM

PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

PHELCOM

Eyer 2 with Ocular Surface Module with blue excitation.

Optomed Aurora Camera with Optomed Aurora Anterior Module with blue excitation.

The meibography images obtained with the Eyer 2 are equivalent to those produced by the LipiView II Ocular Surface Interferometer, as shown in the images below:

Eyer 2 Ocular Surface with NIR excitation.

LipiView II meibography.

A difference between the subject device and the predicate and reference devices is that the Eyer 2® provides infrared fundus imaging. The infrared fundus image, together with the color fundus image and the green channel image, is automatically generated as part of the color fundus photography workflow, without requiring a separate imaging mode or additional user actions. The infrared fundus image is acquired immediately prior to the white-light exposure used for color fundus photography, being a frame saved from the image preview mode.

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PHELCOM TECHNOLOGIES

Traditional 510(k) Premarket Submission

Eyer 2

K251353

P H E L C O M

A typical result of an infrared fundus image acquired with the Eyer 2®

Set of images generated after image capture (color, infrared, and green channel)



- Display

For the display system, Eyer 2 and Eyer Retinal Camera have similar image resolution, with the same amount of pixels on the screen. The Optomed Aurora Camera has a display with lower resolution. However, this does not interfere with the safety and effectiveness in relation to the predicates and reference device because all devices have the same final result, which is to capture images and videos from the fundus of the human eye, surface of the human eye and surrounding areas.

The differences between the subject device and the predicate devices is that the Eyer 2 has better image resolution due to the amount of pixels on the screen, that is, the smartphone models used to capture images of the fundus of the eye.

- Data storage

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PHELCOM TECHNOLOGIES
Traditional 510(k) Premarket Submission
Eyer 2
K251353
P H E L C O M

Eyer 2 and Eyer Retinal Camera uses the internal memory of the smartphone whereas the Optomed Aurora Camera uses SD card.

- Battery
The battery of the predicate Optomed Aurora Camera has 2600 mAh, the battery of the predicate Eyer Retinal camera has 3000 mAh, and the subject has 4000 mAh (for Samsung Galaxy S21 model), 3700 mAh (for Samsung Galaxy S22 model) and 3900 mAh (for Samsung Galaxy S23 model) which demonstrates that the subject device has a larger capacity of battery, which guarantees more autonomy. But this does not affect the effectiveness or safety of the device.

- Data collection
Eyer 2 and Eyer Retinal Camera use Wifi whereas the Optomed Aurora Camera uses USB for data transmission.

- Field of view
The field of view of the subject and predicate devices has a slight difference that is not significant for the intended use.

- Camera
About the camera sensor specification, the subject device uses a camera with maximum resolution of 12 Mp, one of the predicates, the Eyer Retina Camera uses the same type of camera with maximum resolution of 12 Mp. The other predicate, the Optomed Aurora Camera uses a camera with maximum resolution of 5 Mp.

Therefore, the subject device has a similar quality of image and resolution in relation to the Eyer Retinal Camera, and better quality and resolution in relation to the Optomed Aurora Camera, however it does not influence the indication for uses or affect the safety and effectiveness of the device.

## 6. Performance Data

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

- Electrical safety (ES) and electromagnetic compatibility (EMC)
Eyer 2 was tested according to all suitable clauses of IEC 60601-1:2005 + A1:2012 + A2:2020 (Edition 3.2) (Safety) and IEC 60601-1-2:2014 (Edition 4.0).

- Optical Safety
Eyer 2 were tested according to the standard ANSI Z80.36:2021.

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PHELCOM TECHNOLOGIES
Traditional 510(k) Premarket Submission
Eyer 2
K251353
P H E L C O M

- Optical Performance
Eyer 2 fulfills the requirements of standard ISO 10940:2009 - Ophthalmic instruments - Fundus Camera.

- Software Verification and Validation
Software verification and validation were conducted to ensure the fulfillment of the system requirements and functionality. Eyer 2 complies with standard IEC 62304:2015, with Class A, no injury or damage to health is possible.

- Environmental testing
Eyer 2 was tested according to ISO 15004-1:2020 and IEC 60601-1 standard to verify the mechanical stress and ambient conditions for use and storage as prescribed for the device. The devices fulfill the requirements of the standard.

- Biocompatibility
Eyer 2 has an Eyecap that contacts skin around the eye during normal usage of the device. A piece made of an elastomeric material that touches the patient's skin during the exam is used to give firmness to the manipulation and create an environment isolated from external light.

The chosen material was SILPURAN 2420 from manufacturer WACKER and is a non-toxic silicone that has a certificate of conformity with ISO 10993 standard and USP Class IV Biological Tests.

Conclusion
In conclusion, Phelcom Technologies believes that we have established the substantial equivalence of the subject Eyer 2 to the predicate and reference devices. No new issues of safety or effectiveness are introduced by using this device. The basis for our conclusion is reached through a successful review of product design specifications and testing results compared to the predicates and reference device.

TEM04 - Rev00 - Feb 2024