Verily Numetric Retinal Camera

FDA 510(k) K242508 · Verily Life Sciences, LLC

Substantially Equivalent

510(k) numberK242508

Submission

Device name
Verily Numetric Retinal Camera
Applicant
Verily Life Sciences, LLC
South San Francisco, CA, US
Received
August 22, 2024
Decision date
December 9, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
HKI – Camera, Ophthalmic, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1120
Specialty
Ophthalmic

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Questions and answers

When was Verily Numetric Retinal Camera cleared by the FDA?

Verily Numetric Retinal Camera (K242508) received a 510(k) decision of Substantially Equivalent on December 9, 2024, 109 days after the submission was received.

What is the product code of K242508?

The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.