HPL · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1290
Classification
FDA Product Code
HPL
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.1290
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic 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.)