PJZ · Camera, Ophthalmic, General-Use
Ophthalmic · 21 CFR 886.1120 · Class 2
Overview
| Product Code | PJZ |
|---|---|
| Device Name | Camera, Ophthalmic, General-Use |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
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 (0 of 0)
No cleared devices on record.
