FDA 510(k)

Eyer 2

K-Number: K251353 · 2026-01-16

Decision Date2026-01-16

Product CodeHKI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Eyer 2 is the device name listed in this FDA 510(k) record. The listed applicant is Phelcom Technologies. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251353. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eyer 2?

Eyer 2 is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Phelcom Technologies. The 510(k) number is K251353.

When did Eyer 2 receive FDA 510(k) clearance?

Eyer 2 received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251353.

Who is the listed applicant for Eyer 2?

The FDA 510(k) record lists Phelcom Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eyer 2?

The FDA product code for Eyer 2 is HKI.

Other records listing Phelcom Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221329Eyer Retinal Camera NM-STD

Related Devices (Code: HKI)

K253176TearViewBeyond 700 Pty, Ltd.K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd K250683Resolve Fundus CameraOptain Health, Inc.K243664Sentinel CameraAi Optics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.