# K033354: Femtec Laser Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: 20/10 Perfect Vision Optische Gerate GmbH
- Decided: Feb 18, 2004 after 121 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913697 (1991). 6 ancestors in all.
52 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013941: Pulsion FS Laser Keratome, Intra Lase Corp. (2002) Summary page 2.
- K010260: Hansatome Microkeratome, Bausch & Lomb, Inc. (2001) Summary page 2.

## Most influential descendants
- 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
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own

## Indications for use
The FemTecTM Laser Microkeratome is indicated for use in the creation 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/K033354
Methodology: https://510kreport.com/methodology