DeviceClearance

Product code HPL— Ophthalmic

360 DEGREE FIXATION LIGHT

Classification name
Device, Fixation, Ac-Powered, Ophthalmic
Device class
Class 1
Regulation
21 CFR 886.1290
Advisory panel
Ophthalmic
Total cleared
7
First cleared
Most recent

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.)”

— U.S. Food and Drug Administration, device classification record for product code HPL under 21 CFR 886.1290, via openFDA

Market context for product code HPL

FDA has cleared 7 devices under product code HPL between 1979 and 1994, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code HPL

Recent clearances under product code HPL

Data sourced from openFDA. This site is unofficial and independent of the FDA.