DeviceClearance

Product code HJT— Ophthalmic

AA-1 SYSTEM

Classification name
Haploscope
Device class
Class 1
Regulation
21 CFR 886.1340
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

Market context for product code HJT

FDA has cleared 2 devices under product code HJT, all in 2001, filed by 2 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.

Top applicants under product code HJT

Recent clearances under product code HJT

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