Cleared Traditional

K221329 - Eyer Retinal Camera NM-STD (FDA 510(k) Clearance)

K221329 · Phelcom Technologies · Ophthalmic device

Feb 2023

Decision

292d

Days

Class 2

Risk

K221329 is an FDA 510(k) clearance for the Eyer Retinal Camera NM-STD. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).

Submitted by Phelcom Technologies (São 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 FDA review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K221329 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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