FDA Product Code MXK: Device, Analysis, Anterior Segment
Leading manufacturers include Visia Imaging S.R.L., Intelon Optics, Inc. and Oculus Optikger?te GmbH.
FDA 510(k) Cleared Device, Analysis, Anterior Segment Devices (Product Code MXK)
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 increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MXK have taken an average of 342 days to reach a decision - up from 176 days historically. Manufacturers should account for longer review timelines in current project planning.
MXK devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →