Loupe, Binocular, Low Power

FDA product code HJH · Class I (low risk) · 21 CFR 886.5120 · Ophthalmic

3510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K874845Malis Surgical LoupesHJH · Traditional Valley Forge Scientific Corp.12/23/1987SE
K863983Exeter Operating LoupeHJH · Traditional Exeter Instruments, Inc.11/10/1986SE
K830878Binocular LoupeHJH · Traditional Almore Intl., Inc.04/06/1983SE