# K101006: Wavelight FS200 Laser System Model: FS200

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd.
- Decided: Oct 21, 2010 after 192 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913697 (1991). 30 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3, Intra Lase Corp. (2006) Summary page 1.
- K032910: Carriazo Pendular, Schwind Eye-Tech-Solutions GmbH & Co. KG (2004) Summary page 1.
- K073404: Ifs Laser System, Intra Lase Corp. (2008) Summary page 1.

## Most influential descendants
- K120732: Lenssx Laser System (2012), 12 descendants of its own
- K121031: Wavelight FS200 Patient Interface 1505 (2012), 10 descendants of its own
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- K132534: Victus Femtosecond Laser Platform (2014), 5 descendants of its own
- K123120: Lensx Laser System (2012), 5 descendants of its own

## Recalls of this device
- Apr 18, 2011 · Not classified · Z-2292-2011: The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.

## Indications for use
The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use: In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. In the creation of a lamnellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a penetrating cut/incision for penetrating keratoplasty and for comneal harvesting.

Source page: https://510kreport.com/device/K101006
Methodology: https://510kreport.com/methodology