# K014000: Vistitome 20-10 Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Biovision AG
- Decided: Mar 11, 2002 after 97 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 K010260 (2001). 1 ancestor in all.
61 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

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

## 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 Visitome 20-10 Microkeratome is indicated for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K014000
Methodology: https://510kreport.com/methodology