21 CFR 886.1290 — Device, Fixation, Ac-Powered, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1290
Identification
A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)
Classification Rationale
Class I (general controls). The device 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 |
|---|---|---|---|---|
| HPL | Device, Fixation, Ac-Powered, Ophthalmic | 1 | 7 | |
| NXR | Fixation, Vision Training, Binocular | 1 | 1 | |
| SBN | Digital Therapy Device For Convergence Insufficiency | 1 | 1 | SaMD |
