# K972808: Hansatome Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Vision Corp.
- Decided: Oct 24, 1997 after 88 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- 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 K913697 (1991). 1 ancestor in all.
80 later devices descend from it; 7 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913697: Automatic Corneal Shaper, Hansa Research & Development, Inc. (1991) Summary page 1.

## Most influential descendants
- K993153: Intralase 600C Laser Keratome (1999), 66 descendants of its own
- K013941: Pulsion FS Laser Keratome (2002), 65 descendants of its own
- K981741: Carriazo Barraquer Microkeratome (1998), 63 descendants of its own
- K031960: Intralase FS Laser (2003), 61 descendants of its own
- K021640: Hansatome Excellus Microkeratome (2002), 61 descendants of its own

## Indications for use
The Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the comea.

Source page: https://510kreport.com/device/K972808
Methodology: https://510kreport.com/methodology