# K913697: Automatic Corneal Shaper

- Pathway: 510(k) (Traditional)
- Applicant: Hansa Research & Development, Inc.
- Decided: Nov 5, 1991 after 78 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
No predicates in its family tree.
85 later devices descend from it; 7 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972808: Hansatome Microkeratome (1997), 80 descendants of its own
- 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

Source page: https://510kreport.com/device/K913697
Methodology: https://510kreport.com/methodology