# K053511: DA Vinci Femtosecond Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Sie Ltd Surgical Instrument Engineering
- Decided: Mar 10, 2006 after 84 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.
No later device cites it as a predicate yet.
0 of 7 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 5.
- K993190: Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis), Surgical Instrument Systems (Sis), Ltd. (2000) Summary page 4.

## Indications for use
The Da VinciTM Femtosecond Surgical Laser is an ophthalmic surgical laser 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/K053511
Methodology: https://510kreport.com/methodology