DeviceClearance

Product code HKI— Ophthalmic

DIGITAL RETINAL CAMERA

Classification name
Camera, Ophthalmic, Ac-Powered
Device class
Class 2
Regulation
21 CFR 886.1120
Advisory panel
Ophthalmic
Total cleared
157
First cleared
Most recent

Market context for product code HKI

FDA has cleared 157 devices under product code HKI between 1977 and 2026, filed by 91 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

last 15 years

Top applicants under product code HKI

Recent clearances under product code HKI

1–100 of 157

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