# K130565: Specular Microscope Cem-530

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Nov 27, 2013 after 268 days
- Product code: NQE (Microscope, Specular)
- 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: 4 generations back to K920906 (1992). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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 2.

## Most influential descendants
- K151706: Specular Microscope CEM- 530 (2016), 1 descendant of its own
- K173980: Specular Microscope CEM-530 (2018), 0 descendants of its own

## Recalls of this device
- Feb 25, 2019 · Class III · Z-0771-2020: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

## Indications for use
The Nidek Specular Microscope CEM-530 isa non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the comeal endothelium and for measurement of the thickness of the cornea.

Source page: https://510kreport.com/device/K130565
Methodology: https://510kreport.com/methodology