Zilia Ocular FC (ZIL-10002)
FDA 510(k) K230627 · Zilia, Inc.
510(k) numberK230627
Submission
- Device name
- Zilia Ocular FC (ZIL-10002)
- Applicant
- Zilia, Inc.
Quebec City, CA - Received
- March 6, 2023
- Decision date
- November 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K243600 | 3nethra neo HD FA; 3nethra neo HDHKI · Traditional | Forus Health Pvt.Ltd | 08/14/2025SE |
| K250683 | Resolve Fundus CameraHKI · Traditional | Optain Health, Inc. | 04/30/2025SE |
| K243664 | Sentinel CameraHKI · Traditional | Ai Optics | 12/17/2024SE |
| K242508 | Verily Numetric Retinal CameraHKI · Traditional | Verily Life Sciences, LLC | 12/09/2024SE |
| K241049 | CANON Fundus Camera CR-10 (CR-10)HKI · Special | Canon, Inc. | 05/15/2024SE |
| K231230 | Optina-4C (MHRC-C1N)HKI · Special | Optina Diagnostics, Inc. | 12/05/2023SE |
Questions and answers
When was Zilia Ocular FC (ZIL-10002) cleared by the FDA?
Zilia Ocular FC (ZIL-10002) (K230627) received a 510(k) decision of Substantially Equivalent on November 20, 2023, 259 days after the submission was received.
What is the product code of K230627?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.