2 devices · 2 companies · 2019 to 2025
Product code QER: Camera, Ophthalmic, Slit-Scanning
2 devices under product code QER, 2019 to 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Camera, Ophthalmic, Slit-Scanning. 21 CFR 886.1120, Class II. An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| CLARUSK243878 · 510(k) | Carl Zeiss Meditec, Inc. | Ophthalmic | database entry | |
| CLARUSK191194 · 510(k) | Carl Zeiss Meditec, Inc | Ophthalmic | database entry |
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