Product code HJH— Ophthalmic

BINOCULAR LOUPE

Classification name: Loupe, Binocular, Low Power
Device class: Class 1
Regulation: 21 CFR 886.5120
Advisory panel: Ophthalmic
Total cleared: 3
First cleared: 1983-04-06
Most recent: 1987-12-23

Market context for product code HJH

FDA has cleared 3 devices under product code HJH between 1983 and 1987, filed by 3 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

19871 clearance
19861 clearance
19831 clearance

Top applicants under product code HJH

Valley Forge Scientific Corp.1 clearance
Exeter Instruments, Inc.1 clearance
Almore Intl., Inc.1 clearance

Recent clearances under product code HJH

K874845 — MALIS SURGICAL LOUPESValley Forge Scientific Corp.·1987-12-23
K863983 — EXETER OPERATING LOUPEExeter Instruments, Inc.·1986-11-10
K830878 — BINOCULAR LOUPEAlmore Intl., Inc.·1983-04-06

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