# K994340: Clinical Specular Microscope, Model Hai CL-1000XYZ

- Pathway: 510(k) (Abbreviated)
- Applicant: Hai Laboratories, Inc.
- Decided: Sep 20, 2000 after 272 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040373: Kerato Analyzer (Eka) (2004), 0 descendants of its own

## Indications for use
The Clinical Specular Microscope Model HAI CL-1000xyz is inteaded.to be used to examine the cornea of the eye.

Source page: https://510kreport.com/device/K994340
Methodology: https://510kreport.com/methodology