# K980357: Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter

- Pathway: 510(k) (Traditional)
- Applicant: Konan, Inc.
- Decided: Apr 24, 1998 after 85 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920906 (1992). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950091: Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000, Konan Medical, Inc. (1995) Summary page 4.
- K920906: DGH-500 Pachymeter, Dgh Technology, Inc. (1992) Summary page 4.

## Most influential descendants
- K062763: Noncon Robo Pachy F&a (2008), 10 descendants of its own
- K120264: Konan Specular Microscope Xiv (2012), 7 descendants of its own
- K130565: Specular Microscope Cem-530 (2013), 2 descendants of its own
- K151706: Specular Microscope CEM- 530 (2016), 1 descendant of its own
- K142417: SP-1PSpecular Microscope (2015), 1 descendant of its own

## Indications for use
The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a non-contact ophthalmic microscope and camera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical means. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.

Source page: https://510kreport.com/device/K980357
Methodology: https://510kreport.com/methodology