# K924588: Zeiss Laser Indirect Ophthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Jul 9, 1993 after 302 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K062336: Optimedica Laser Indirect Ophthalmoscope (2006), 1 descendant of its own
- K123056: Pascal Laser Indirect Ophthalmoscope (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K924588
Methodology: https://510kreport.com/methodology