The following data is part of a premarket notification filed by Alcon Research, Ltd. Dba Alcon Laboratories, Inc. with the FDA for Wavelight Fs200 Laser System.
| Device ID | K141476 |
| 510k Number | K141476 |
| Device Name: | WAVELIGHT FS200 LASER SYSTEM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 |
| Contact | Bob Lundberg |
| Correspondent | Amy Tezel ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-04 |
| Decision Date | 2014-09-30 |
| Summary: | summary |