DeviceClearance

Product code HJO— Ophthalmic

IOLMASTER 500

Classification name
Biomicroscope, Slit-Lamp, Ac-Powered
Device class
Class 2
Regulation
21 CFR 886.1850
Advisory panel
Ophthalmic
Total cleared
108
First cleared
Most recent

Market context for product code HJO

FDA has cleared 108 devices under product code HJO between 1980 and 2026, filed by 69 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 HJO

Recent clearances under product code HJO

1–100 of 108

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