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Device, Fixation, Ac-Powered, Ophthalmic

FDA product code HPL · 7 cleared devices

Class 1 Ophthalmic
Regulation
21 CFR 886.1290
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1979-01-26 – 1994-08-29

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.)

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