The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Ladarwave Customcornea Wavefront System.
| Device ID | K062930 |
| 510k Number | K062930 |
| Device Name: | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM |
| Classification | Aberrometer, Ophthalmic |
| Applicant | ALCON RESEARCH, LTD. 2501 DISCOVERY DR. SUITE 500 Orlando, FL 32826 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson ALCON RESEARCH, LTD. 2501 DISCOVERY DR. SUITE 500 Orlando, FL 32826 |
| Product Code | NCF |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-11-08 |
| Summary: | summary |