QER · Camera, Ophthalmic, Slit-Scanning
Ophthalmic · 21 CFR 886.1120 · Class 2
Overview
| Product Code | QER |
|---|---|
| Device Name | Camera, Ophthalmic, Slit-Scanning |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Classification Rationale
Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | Apr 17, 2025 | SESE |
| K191194 | CLARUS | Carl Zeiss Meditec, Inc. | Jun 25, 2019 | SESE |
| K181444 | CLARUS | Carl Zeiss Meditec, Inc. | Jan 10, 2019 | SESE |
Top Applicants
- Carl Zeiss Meditec, Inc. — 3 clearances
