# K170171: IOLMaster 700

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Apr 6, 2017 after 77 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 39 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143275: IOLMaster700, Carl Zeiss Meditec, Inc. (2015) Summary page 4.

## Most influential descendants
- K173771: IOLMaster 700 (2018), 1 descendant of its own
- K252633: Unity DX (Udx) (2025), 0 descendants of its own
- K191051: ARGOS (2019), 0 descendants of its own

## Recalls of this device
- Jun 25, 2018 · Class II · Z-0108-2019: Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and 

## Indications for use
The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: • Lens thickness • Corneal curvature and thickness • Axial length • Anterior chamber depth • Pupil diameter • White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Source page: https://510kreport.com/device/K170171
Methodology: https://510kreport.com/methodology