CLARUS is an AI-enabled medical device from Carl Zeiss Meditec, Inc that the U.S. FDA cleared through 510(k) K191194 on June 25, 2019. Its lead review panel is Ophthalmic and its primary product code is QER (Camera, Ophthalmic, Slit-Scanning).
See also all FDA AI clearances in 2019.
Key facts
| Submission number | K191194 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Carl Zeiss Meditec, Inc |
| Lead review panel | Ophthalmic |
| Primary product code | QER — Camera, Ophthalmic, Slit-Scanning |
| Applicant (openFDA) | Carl Zeiss Meditec, Inc. |
| Applicant location | Dublin, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 886.1120 |
| 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. CLARUS went through this pathway (K191194).
openFDA lists it as a Class 2 device under 21 CFR 886.1120. Class II devices are moderate risk and are subject to general and special controls.
Product code QER covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Carl Zeiss Meditec, 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.