The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Wavelight Fs200 Patient Interface.
| Device ID | K190392 |
| 510k Number | K190392 |
| Device Name: | WaveLight FS200 Patient Interface |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Alcon Laboratories, Inc. 20511 Lake Forest Drive Lake Forest, CA 92630 |
| Contact | Ophelia Biggs |
| Correspondent | Ophelia Biggs Alcon Laboratories, Inc. 20511 Lake Forest Drive Lake Forest, CA 92630 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380659982989 | K190392 | 000 |