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Eyer 2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251353

by Phelcom Technologies

Identifiers

510(k) Number
K251353 FDA 510(k)
FDA Product Code
HKI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.1120 FDA 510(k)
Regulation Number
886.1120 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Eyer 2 is a non-mydriatic retinal camera designed for fundus imaging. It provides portable, high-resolution retinal photography for eye examinations.

The device is manufactured by Phelcom Technologies and has received FDA 510(k) clearance with the product code HKI. It is an AC-powered ophthalmic camera with multiple registration numbers and is intended for use in ophthalmic settings.

Frequently asked questions

What is the Eyer 2 used for?

The Eyer 2 is a non-mydriatic retinal camera designed for fundus imaging, providing portable, high-resolution retinal photography for comprehensive eye examinations in ophthalmic settings.

Is the Eyer 2 a single-use or reusable device?

The Eyer 2 is an AC-powered ophthalmic camera designed for repeated use in clinical settings, not as a single-use device. It is built to withstand multiple examinations while maintaining image quality.

What regulatory approvals does the Eyer 2 have?

The Eyer 2 has received FDA 510(k) clearance with the product code HKI, classified as substantially equivalent to predicate devices. It is intended for use in ophthalmic settings with multiple registration numbers.

How is the Eyer 2 supplied and stored?

The Eyer 2 is an AC-powered device that requires appropriate electrical connections. It should be stored in a clean, dry environment at the manufacturer's recommended conditions to maintain optimal performance and extend its operational lifespan.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Eyer2 Essential - PHELCOM Technologies, PHELCOM Technologies, Non-mydriatic retinal camera - Eyer2 - Phelcom Technologies - retinal ..., Phelcom Eyer2 Portable Fundus Camera - proeye.com, Eyer2 fundus and ocular surface camera brochure - Phelcom Technologies ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Phelcom Technologies

Sources (1)

  • FDA 510(k) K251353 24 fields · synced Sep 22, 2026