# K191051: ARGOS

- Pathway: 510(k) (Traditional)
- Applicant: Santec Corporation
- Decided: May 16, 2019 after 27 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150754: ARGOS, Santec Corporation (2015) Summary page 5.
- K143275: IOLMaster700, Carl Zeiss Meditec, Inc. (2015) Summary page 5.
- K170171: IOLMaster 700, Carl Zeiss Meditec, AG (2017) Summary page 5.

## Indications for use
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, White-to-white (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

Source page: https://510kreport.com/device/K191051
Methodology: https://510kreport.com/methodology