FDA product code QER: Camera, Ophthalmic, Slit-Scanning
QER is the FDA product code for camera, ophthalmic, slit-scanning. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under QER, 1 in the last five years. The average 510(k) review took 132 days (median 120); 120 days on average over the last three years.
Definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Ophthalmic, Slit-Scanning |
| Device class | Class II |
| Regulation | 21 CFR 886.1120 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for QER
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 138 |
| 2025 | 1 | 120 |
Compare with all 510(k) review times · Search every QER clearance
Top QER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carl Zeiss Meditec, Inc. | 3 | 2025-04-17 |
Most recent QER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243878 | Carl Zeiss Meditec, Inc. | CLARUS (700) | 2025-04-17 | 120 |
| K191194 | Carl Zeiss Meditec, Inc. | CLARUS | 2019-06-25 | 53 |
| K181444 | Carl Zeiss Meditec, Inc. | CLARUS | 2019-01-10 | 223 |
Recalls for QER devices
openFDA lists no recalls for product code QER.
Frequently asked questions
What is FDA product code QER?
QER is the FDA product code for camera, ophthalmic, slit-scanning. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel.
What device class is QER?
Class II, regulation 21 CFR 886.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code QER?
Across 3 cleared submissions the average was 132 days from receipt to decision (median 120).
Which companies have the most QER clearances?
Carl Zeiss Meditec, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QER
- Run a recall and safety report across every QER manufacturer
- Watch product code QER for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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