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FDA 510(k)

Eyer 2

K-Number: K251353 · 2026-01-16

ApplicantPhelcom Technologies
Decision Date2026-01-16
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Eyer 2 is a medical device manufactured by Phelcom Technologies. It received FDA 510(k) clearance on 2026-01-16 under approval 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. It is manufactured by Phelcom Technologies. The 510(k) number is K251353.

When was Eyer 2 approved by the FDA?

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

What company makes Eyer 2?

Eyer 2 is manufactured by Phelcom Technologies.

What is the FDA product code for Eyer 2?

The FDA product code for Eyer 2 is HKI.

Other Devices by Phelcom Technologies

K221329Eyer Retinal Camera NM-STD

Related Devices (Code: HKI)

K161727Eyenez Ophthalmic CameraEyenez, LLC K152729MICROPERIMETER MP-3Nidek Co., Ltd. K153239LSFG-NAVISoftcare Co., Ltd. K152869LipiView II Ocular Surface InterferometerTearscience, Inc. K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical K163021HAAG-STREIT FUNDUS MODULE 300Optomed OY

Official Source

View on FDA Database →

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

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