# K012416: Confoscan 2 Confocal Microscope

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Technologies Srl
- Decided: Oct 26, 2001 after 88 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- 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: 2 generations back to K912514 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971953: Confoscan, Tomey Corporation USA (1997). Our OCR of the scanned summary read K972953, FDA’s number for Palaurex 76KF (Aurex Precious Metal Industries (Pty)Ltd). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ConfoScan Confocal Microscope”. Summary page 3.

## Most influential descendants
- K042742: Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) (2004), 0 descendants of its own

## Indications for use
The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye.

Source page: https://510kreport.com/device/K012416
Methodology: https://510kreport.com/methodology