DeviceClearance

Product code MXK— Ophthalmic

ARGOS

Classification name
Device, Analysis, Anterior Segment
Device class
Class 2
Regulation
21 CFR 886.1850
Advisory panel
Ophthalmic
Total cleared
23
First cleared
Most recent

Market context for product code MXK

FDA has cleared 23 devices under product code MXK between 1999 and 2026, filed by 15 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 MXK

Recent clearances under product code MXK

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