ARGOS
SANTEC CORPORATION
santec OIS Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012423824 | 3012423824 | santec OIS Corporation | 1 | N | 2026-01-01 | 5823 Ohkusa-Nenjozaka Komaki Aichi JP 4850802 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 186933 | 1363854410 | K191051 | ARGOS | MXK | 2019-05-16 |
| 186933 | 1574094196 | K150754 | ARGOS | MXK | 2015-10-02 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MXK | 4 | 2019-05-16 |
PMN#
ARGOS
SANTEC CORPORATION
GUDID#
OPTICAL BIOMETER - ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography (SS-OCT). The device is intended to acquire ocular measurements as well asperform calculations to determine the appropriate intraocular lens (IOL) power and typefor implantation during intraocular lens placement. ARGOS measures the following 9parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness,K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-white(corneal diameter) and Pupil Size. The Reference Image functionality is intended for useas a preoperative and postoperative image capture tool.It is intended for use by ophthalmologists, physicians, and other eye-care professionalsand may only be used under the supervision of a physician.
2019-05-22
OPTICAL BIOMETER - ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, Whiteto- white (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
2017-05-01