# K010260: Hansatome Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Apr 27, 2001 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
No predicates in its family tree.
67 later devices descend from it; 4 cite it directly.
0 of 68 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
- K021640: Hansatome Excellus Microkeratome (2002), 61 descendants of its own
- K014000: Vistitome 20-10 Microkeratome (2002), 61 descendants of its own
- K032910: Carriazo Pendular (2004), 58 descendants of its own
- K073404: Ifs Laser System (2008), 56 descendants of its own
- K033354: Femtec Laser Microkeratome (2004), 52 descendants of its own

Source page: https://510kreport.com/device/K010260
Methodology: https://510kreport.com/methodology