# K121031: Wavelight FS200 Patient Interface 1505

- Pathway: 510(k) (Abbreviated)
- Applicant: Alcon Research, Ltd.
- Decided: Jun 21, 2012 after 77 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: 9 generations back to K913697 (1991). 31 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101006: Wavelight FS200 Laser System Model: FS200, Alcon Research, Ltd. (2010) Summary page 1.

## Most influential descendants
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- 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

## Indications for use
The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Source page: https://510kreport.com/device/K121031
Methodology: https://510kreport.com/methodology