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.

Clearance details

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

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