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.)
Leading manufacturers include Carl Zeiss, Inc. and Storz Instrument Co..
7
Total
7
Cleared
157d
Avg days
1979
Since
FDA 510(k) Cleared Device, Fixation, Ac-powered, Ophthalmic Devices (Product Code HPL)
7 devices
Cleared
Aug 29, 1994
STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY
Storz Instrument Co.
Ophthalmic
509d
Cleared
Nov 12, 1985
KERATOLUX
Carl Zeiss, Inc.
Ophthalmic
13d