Product code HPL

Device name

Device, Fixation, Ac-Powered, Ophthalmic

Medical specialty

Ophthalmic

Device class

1

Regulation number

886.1290

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.)

Source

FDA openFDA device classification dataset