510(k) K242508
K242508 is an FDA 510(k) premarket notification submitted by Verily Life Sciences, LLC for the device "Verily Numetric Retinal Camera". The FDA issued a decision of Substantially Equivalent on December 9, 2024. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Verily Life Sciences, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2024
- Date Received
- August 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type