# K190392: WaveLight FS200 Patient Interface

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Mar 26, 2019 after 35 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: 10 generations back to K913697 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121031: Wavelight FS200 Patient Interface 1505, Alcon Research, Ltd. (2012) Summary page 4.

## Indications for use
The WaveLight FS200 Patient Interface 1515 is indicated to be used only with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Source page: https://510kreport.com/device/K190392
Methodology: https://510kreport.com/methodology