HPL

Device, Fixation, Ac-Powered, Ophthalmic

Product code

HPL

Device name

Device, Fixation, Ac-Powered, Ophthalmic

Device class

Class 1

21 CFR

21 CFR 886.1290

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

7 (all years; only the last 3 years are listed here)

FDA classification 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.)

Definition text from the FDA device classification database (U.S. federal government work, public domain).