MXK · Class II · 21 CFR 886.1850

FDA Product Code MXK: Device, Analysis, Anterior Segment

Leading manufacturers include Oculus Optikgerate GmbH, Santec Corporation and Oculus Optikger?te GmbH.

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
1–23 of 23
Cleared Mar 13, 2026
Pentacam® Cornea OCT
K251848
Oculus Optikger?te GmbH
Ophthalmic · 270d
Cleared Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
K252348
Tomey Corporation
Ophthalmic · 142d
Cleared Aug 16, 2024
BOSS™
K223700
Intelon Optics, Inc.
Ophthalmic · 613d
Cleared Jun 29, 2023
MYAH
K222933
Visia Imaging S.R.L.
Ophthalmic · 276d
Cleared Mar 01, 2022
MYAH
K211868
Visia Imaging S.R.L.
Ophthalmic · 258d
Cleared Jul 14, 2021
Myopia Master
K202989
Oculus Optikger?te GmbH
Ophthalmic · 287d
Cleared Oct 21, 2020
Pentacam AXL Wave
K201724
Oculus Optikgerate GmbH
Ophthalmic · 120d
Cleared Jul 25, 2019
Galilei G6 Lens Professional
K182659
Sis Ag, Surgical Instrument Systems
Ophthalmic · 303d
Cleared May 16, 2019
ARGOS
K191051
Santec Corporation
Ophthalmic · 27d
Cleared Jan 20, 2016
Pentacam AXL
K152311
Oculus Optikgerate GmbH
Ophthalmic · 159d
Cleared Oct 02, 2015
ARGOS
K150754
Santec Corporation
Ophthalmic · 193d
Cleared Sep 11, 2008
PARKONE
K073508
Oculus Optikgerate GmbH
Ophthalmic · 273d
Cleared Jul 20, 2007
ALLEGRO OCULYZER
K071183
Wavelight AG
Ophthalmic · 81d
Cleared Jan 13, 2006
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
K052935
Heidelberg Engineering
Ophthalmic · 86d
Cleared Sep 28, 2005
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K051940
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 72d
Cleared Jan 28, 2005
PACHYCAM
K041841
Oculus Optikgerate GmbH
Ophthalmic · 204d
Cleared Oct 13, 2004
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742
Heidelberg Engineering
Ophthalmic · 9d
Cleared Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284
Nidek, Inc.
Ophthalmic · 113d
Cleared Mar 05, 1999
ORBSCAN
K984443
Technolas Perfect Vision GmbH
Ophthalmic · 81d

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 →