The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Wavelight Fs200 Patient Interface 1505.
| Device ID | K121031 |
| 510k Number | K121031 |
| Device Name: | WAVELIGHT FS200 PATIENT INTERFACE 1505 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Michael Buenger |
| Correspondent | Michael Buenger ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-06-21 |
| Summary: | summary |