# K971953: Confoscan

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation USA
- Decided: Aug 14, 1997 after 78 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: 1 generation back to K912514 (1991). 3 ancestors in all.
2 later devices descend 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)
- K912514: Tandem Scanning Microscope, Tandem Scanning Corp. (1991) Summary page 1.
- K944910: Tomey EM-1000 Specular  Microscope, Tomey Corporation USA (1994) Summary page 1.
- K945959: Video Vision Analyzer (Viva), VRB 100, Tomey Corporation USA (1995) Summary page 1.

## Most influential descendants
- K012416: Confoscan 2 Confocal Microscope (2001), 1 descendant of its own
- K042742: Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) (2004), 0 descendants of its own

## Indications for use
The Tomey "ConfoScan" Confocal Microscope is intended for use as a diagnostic tool for looking at the cell layers of the anterior parts of the eye.

Source page: https://510kreport.com/device/K971953
Methodology: https://510kreport.com/methodology