DeviceClearance

Product code HKC— Ophthalmic

BINOCULAR MAGNIFIER 2X

Classification name
Spectacle Microscope, Low-Vision
Device class
Class 1
Regulation
21 CFR 886.5540
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

Market context for product code HKC

FDA has cleared 1 device under product code HKC, all in 1983, filed by 1 applicant company. 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 HKC

Recent clearances under product code HKC

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