Santec Corporation, a leading designer and manufacturer of advanced optical components, tunable lasers, optical test & measurement and OCT systems, today announced the US FDA approval for the latest version of the award winning SS-OCT Biometer; ARGOS® , the ARGOS® is marketed under the Santec medical brand MOVU.
ARGOS® SS-OCT biometer
Details of the US FDA Approval:
1) FDA approved product name (Model number) : ARGOS (ARGOS ver1.5)
2) FDA 510 (k) number: K191051
3) FDA approval date: May 16, 2019
4) 510(k) Premarket Notification
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191051
The latest ARGOS®, that incorporates reference image capture, is already CE mark certified and Japanese regulatory affairs approved, and is scheduled to be launched from the second half of 2019 in certain regions including Japan, USA, Australia and Europe.
The exclusive global distribution of ARGOS® by Alcon Inc. (Head office: Geneva, Switzerland) was announced earlier this month:
”Santec and Alcon make strategic alliance on Swept Source Optical Coherence Tomography biometer”
https://www.santec.com/en/14675