# K912581: Zeiss Confocal Laser Scanning Ophthalmoscope (Clso)

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Dec 23, 1991 after 194 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 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
- K042740: Isc-1000 Pentax Confocal Laser System (2004), 16 descendants of its own
- K042741: EC-3870CILK, Confocal Video Colonoscope (2004), 15 descendants of its own
- K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex (2006), 13 descendants of its own
- K051585: F-400 System (2005), 13 descendants of its own
- K111047: Cellvizio 100 Series System with Confocal Miniprobes (2011), 12 descendants of its own

Source page: https://510kreport.com/device/K912581
Methodology: https://510kreport.com/methodology