HPL · Class I · 21 CFR 886.1290

FDA Product Code HPL: Device, Fixation, Ac-powered, Ophthalmic

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.)

7
Total
7
Cleared
157d
Avg days
1979
Since

FDA 510(k) Cleared Device, Fixation, Ac-powered, Ophthalmic Devices (Product Code HPL)

7 devices
1–7 of 7
No devices found for this product code.

About Product Code HPL - Regulatory Context