EyeArt v2.2.0 is an AI-enabled medical device from Eyenuk, Inc. that the U.S. FDA cleared through 510(k) K223357 on June 16, 2023. Its lead review panel is Ophthalmic and its primary product code is PIB (Diabetic Retinopathy Detection Device).
See also all FDA AI clearances in 2023.
Key facts
| Submission number | K223357 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Eyenuk, Inc. |
| Lead review panel | Ophthalmic |
| Primary product code | PIB — Diabetic Retinopathy Detection Device |
| Applicant (openFDA) | Eyenuk, Inc. |
| Applicant location | Los Angeles, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 886.1100 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EyeArt v2.2.0 went through this pathway (K223357).
openFDA lists it as a Class 2 device under 21 CFR 886.1100. Class II devices are moderate risk and are subject to general and special controls.
Product code PIB covers 7 devices on the FDA AI list. By decision date, this device is #6 of 7 under that code. Eyenuk, Inc. has 2 AI-enabled devices on the list, and the Ophthalmic panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code PIB)
- AEYE-DSAEYE Health Inc. · Ophthalmic
- AEYE-DSAEYE Health, Inc. · Ophthalmic
- IDx-DR v2.3Digital Diagnostics Inc. · Ophthalmic
- IDx-DRDigital Diagnostics Inc. · Ophthalmic
- EyeArtEyenuk, Inc · Ophthalmic
- IDx-DRIDx, LLC · Ophthalmic