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 |