MXK

Device, Analysis, Anterior Segment

Product code
MXK
Device name
Device, Analysis, Anterior Segment
Device class
Class 2
21 CFR
21 CFR 886.1850
Medical specialty
Ophthalmic
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
23 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-03-13.

NumberDecision dateApplicantDevice nameSummary
K2518482026-03-13Oculus Optikgeräte GmbHPentacam® Cornea OCTPDF
K2523482025-12-18Tomey CorporationTomey Optical Biometer OA-2000 (OA-2000)PDF
K2237002024-08-16Intelon Optics, Inc.BOSS™FDA

2 summaries are archived here for direct download.

Official FDA classification page: MXK
Classification and pathway per current FDA publications. Data from openFDA (CC0).