# K141476: Wavelight FS200 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
- Decided: Sep 30, 2014 after 118 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913697 (1991). 66 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131207: Femto LDV (TM) Z-Generation Femtosecond Surgical Laser, Surgical Instrument Engineering AG (2013) Summary page 5.
- K113151: Ifs Laser System, Abbott Medical Optics, Inc. (2012) Summary page 5.
- K101006: Wavelight FS200 Laser System Model: FS200, Alcon Research, Ltd. (2010) Summary page 5.
- K121031: Wavelight FS200 Patient Interface 1505, Alcon Research, Ltd. (2012) Summary page 5.

## Most influential descendants
- K173346: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 3 descendants of its own
- K181430: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 2 descendants of its own
- K173660: LenSx Laser System (2018), 2 descendants of its own
- K243896: LenSx Laser System (8065998162) (2025), 1 descendant of its own
- K182795: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 1 descendant of its own

## 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 lamellar cut/resection of the cornea for lamellar keratoplasty. • In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting. • In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea. • In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.

Source page: https://510kreport.com/device/K141476
Methodology: https://510kreport.com/methodology