# K171313: EM-4000 Specular Microscope

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation
- Decided: Jan 19, 2018 after 260 days
- Product code: NQE (Microscope, Specular)
- 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: 4 generations back to K920906 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120264: Konan Specular Microscope Xiv, Konan Medical, Inc. (2012) Summary page 4.

## Indications for use
The EM-4000 Specular Microscope is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

Source page: https://510kreport.com/device/K171313
Methodology: https://510kreport.com/methodology