MMF · Photorefractor
Ophthalmic · 21 CFR 886.1120 · Class 2
Overview
| Product Code | MMF |
|---|---|
| Device Name | Photorefractor |
| 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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934880 | MTI PHOTOSCREENER | Medical Technology and Innovations, Inc. | Apr 6, 1994 | SESE |
Top Applicants
- Medical Technology and Innovations, Inc. — 1 clearance
