The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Alcon Ladarwave Customcornea Wavefront System.
Device ID | K023249 |
510k Number | K023249 |
Device Name: | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM |
Classification | Aberrometer, Ophthalmic |
Applicant | ALCON LABORATORIES, INC. 2501 DISCOVERY DRIVE,SUITE 500 Orlando, FL 32826 -3714 |
Contact | Christy Stevens |
Correspondent | Christy Stevens ALCON LABORATORIES, INC. 2501 DISCOVERY DRIVE,SUITE 500 Orlando, FL 32826 -3714 |
Product Code | NCF |
CFR Regulation Number | 886.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-30 |
Decision Date | 2002-10-18 |
Summary: | summary |