The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal.
Device ID | K123994 |
510k Number | K123994 |
Device Name: | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Contact | Martina Heim, Ph.d., Rac |
Correspondent | Martina Heim, Ph.d., Rac CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-26 |
Decision Date | 2013-02-21 |
Summary: | summary |