The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Dailies Aquacomfort Plus (sphere), Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal.
Device ID | K172066 |
510k Number | K172066 |
Device Name: | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
Contact | Sherri Lakota |
Correspondent | Andreas Friese Alcon / CIBA Vision GmbH Industriering 1 Grosswallstadt, DE 63868 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-07 |
Decision Date | 2017-08-09 |
Summary: | summary |