21 CFR 886.1120 — Camera, Ophthalmic, Ac-Powered
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1120
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 2 | 156 | 3rd Party |
| MMF | Photorefractor | 2 | 1 | |
| PJZ | Camera, Ophthalmic, General-Use | 2 | 0 | |
| QER | Camera, Ophthalmic, Slit-Scanning | 2 | 3 | SaMD, 3rd Party |
| QZP | Camera, Ophthalmic, Non-Prescription | 2 | 0 |
Special Controls
HKI — Camera, Ophthalmic, Ac-Powered
*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.
eCFR
MMF — Photorefractor
*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.
eCFR
PJZ — Camera, Ophthalmic, General-Use
*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.
eCFR
QER — Camera, Ophthalmic, Slit-Scanning
*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.
eCFR
QZP — Camera, Ophthalmic, Non-Prescription
*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.
eCFR
