DeviceClearance

Product code HJA— Ophthalmic

AMERICAN MEDICAL OPTICS PHOTOKERATO

Classification name
Photokeratoscope
Device class
Class 1
Regulation
21 CFR 886.1350
Advisory panel
Ophthalmic
Total cleared
5
First cleared
Most recent

Market context for product code HJA

FDA has cleared 5 devices under product code HJA between 1978 and 1990, filed by 5 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 HJA

Recent clearances under product code HJA

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