# K231676: CALLISTO eye

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Aug 28, 2023 after 80 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K012727 (2002). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180858: CALLISTO eye, Carl Zeiss Meditec, AG (2018) Summary page 5.

## Most influential descendants
- K232944: CALLISTO eye (2023), 0 descendants of its own

## Indications for use
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye. CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

Source page: https://510kreport.com/device/K231676
Methodology: https://510kreport.com/methodology