Santec receives FDA Approval for ARGOS®
Komaki, Japan, May 30, 2019 – 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.
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
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”
ARGOS® SS-OCT biometer
Santec Corporation was established in 1979. It is headquartered in Komaki, Aichi, Japan and has subsidiaries in North America (Santec U.S.A. Corporation in NJ), U.K. (SANTEC Europe Ltd. in London) and China (Santec (Shanghai) Co., Ltd.in Shanghai). Santec is listed on the JASDAQ Market (6777) – a section of the Tokyo Stock Exchange. The company employs 246 staff members and serves a global customer base; including the world’s major telecommunications companies, transmission/sub system manufacturers, internationally recognized research centers and universities. Santec’s product lines include a broad range of advanced optical components, tunable lasers, optical test/measurement and OCT systems for telecommunication, life science, sensing and industry applications.
* ARGOS and MOVU are trademarks or registered trademarks of Santec Corporation.