# K141068: Zeiss Cataract Suite Markerless

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Sep 9, 2014 after 138 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- 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: 7 generations back to K896095 (1990). 16 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101861: Truevision 3D Visualization and Guidance System, Truevision Systems, Incorporated (2010) Summary page 5.

## Most influential descendants
- K143275: IOLMaster700 (2015), 4 descendants of its own
- K170171: IOLMaster 700 (2017), 3 descendants of its own
- K180858: CALLISTO eye (2018), 2 descendants of its own
- K231676: CALLISTO eye (2023), 1 descendant of its own
- K173771: IOLMaster 700 (2018), 1 descendant of its own

## Indications for use
The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices: IOLMaster 500 The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation. This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician. CALLISTO eye CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope. The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions and capsulorhexis. The system utilizes surgeon information for position of graphical guidance tools.

Source page: https://510kreport.com/device/K141068
Methodology: https://510kreport.com/methodology