The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Wavelight Fs200 Laser System Model: Fs200.
| Device ID | K101006 |
| 510k Number | K101006 |
| Device Name: | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380659909412 | K101006 | 000 |