Cleared Traditional

Verily Numetric Retinal Camera

K242508 · Verily Life Sciences, LLC · Ophthalmic
Dec 2024
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K242508 is an FDA 510(k) clearance for the Verily Numetric Retinal Camera, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Verily Life Sciences, LLC (South San Francisco, US). The FDA issued a Cleared decision on December 9, 2024, 109 days after receiving the submission on August 22, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K242508 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2024
Decision Date December 09, 2024
Days to Decision 109 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120