Cleared Traditional

Sentinel Camera

K243664 · Ai Optics · Ophthalmic

Dec 2024

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K243664 is an FDA 510(k) clearance for the Sentinel Camera, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Ai Optics (New York, US). The FDA issued a Cleared decision on December 17, 2024, 20 days after receiving the submission on November 27, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K243664 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2024
Decision Date	December 17, 2024
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF