# K021640: Hansatome Excellus Microkeratome

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Jun 19, 2002 after 30 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: 2 generations back to K913697 (1991). 3 ancestors in all.
61 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972808: Hansatome Microkeratome, Chiron Vision Corp. (1997) Summary page 2.
- K010260: Hansatome Microkeratome, Bausch & Lomb, Inc. (2001)

## Most influential descendants
- K032910: Carriazo Pendular (2004), 58 descendants of its own
- K073404: Ifs Laser System (2008), 56 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own

## Indications for use
The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K021640
Methodology: https://510kreport.com/methodology