DeviceClearance

Product code HKL— Ophthalmic

KOI BLUE FIELD ENTOPTOSCOPE

Classification name
Retinoscope, Ac-Powered
Device class
Class 2
Regulation
21 CFR 886.1780
Advisory panel
Ophthalmic
Total cleared
6
First cleared
Most recent

Market context for product code HKL

FDA has cleared 6 devices under product code HKL between 1980 and 2000, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HKL

Recent clearances under product code HKL

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