Cleared Traditional

Eyer 2

K251353 · Phelcom Technologies · Ophthalmic

Jan 2026

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K251353 is an FDA 510(k) clearance for the Eyer 2, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Phelcom Technologies (S?o Carlos, BR). The FDA issued a Cleared decision on January 16, 2026, 261 days after receiving the submission on April 30, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K251353 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2025
Decision Date	January 16, 2026
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF