Cleared Traditional

Eyer Retinal Camera NM-STD

K221329 · Phelcom Technologies · Ophthalmic

Feb 2023

Decision

292d

Days

Class 2

Risk

About This 510(k) Submission

K221329 is an FDA 510(k) clearance for the Eyer Retinal Camera NM-STD, 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 February 22, 2023, 292 days after receiving the submission on May 6, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K221329 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2022
Decision Date	February 22, 2023
Days to Decision	292 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF