FDA Product Code MXK: Device, Analysis, Anterior Segment
Leading manufacturers include Oculus Optikger?te GmbH, Visia Imaging S.R.L. and Intelon Optics, Inc..
23
Total
23
Cleared
198d
Avg days
1999
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times:
206d avg (recent)
FDA 510(k) Cleared Device, Analysis, Anterior Segment Devices (Product Code MXK)
23 devices
Cleared
Mar 13, 2026
Pentacam® Cornea OCT
Oculus Optikger?te GmbH
Ophthalmic
270d
Cleared
Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
Tomey Corporation
Ophthalmic
142d
Cleared
Aug 16, 2024
BOSS™
Intelon Optics, Inc.
Ophthalmic
613d
Cleared
Jun 29, 2023
MYAH
Visia Imaging S.R.L.
Ophthalmic
276d
Cleared
Mar 01, 2022
MYAH
Visia Imaging S.R.L.
Ophthalmic
258d
Cleared
Jul 14, 2021
Myopia Master
Oculus Optikger?te GmbH
Ophthalmic
287d
Cleared
Oct 21, 2020
Pentacam AXL Wave
Oculus Optikgerate GmbH
Ophthalmic
120d
Cleared
Jul 25, 2019
Galilei G6 Lens Professional
Sis Ag, Surgical Instrument Systems
Ophthalmic
303d
Cleared
May 16, 2019
ARGOS
Santec Corporation
Ophthalmic
27d
Cleared
Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
Nidek, Inc.
Ophthalmic
113d
About Product Code MXK - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code MXK since 1999, with 23 receiving FDA clearance (average review time: 198 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - MXK Product Code
FDA review times for MXK submissions have been consistent, averaging 206 days recently vs 197 days historically.
MXK devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →