Eyer 2— 510(k) K251353

Substantially Equivalent

Phelcom Technologies

FDA 510(k) clearance K251353 for Eyer 2, Substantially Equivalent on 2026-01-16. Applicant: Phelcom Technologies. Device class: 2.

Clearance details

Applicant: Phelcom Technologies
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2025-04-30
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Carlos, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKI

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K243600 — 3nethra neo HD FA2025-08-14
K250683 — Resolve Fundus Camera2025-04-30

More clearances from Phelcom Technologies

K221329 — Eyer Retinal Camera NM-STD2023-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.