The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Dailies Total1, Dailies Total1 Asphere, Dailies Total1 For Astigmatism, Dailies Total1 Multifocal, Dailies Total1 Multifocal Toric.
Device ID | K182782 |
510k Number | K182782 |
Device Name: | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 For ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 |
Contact | Martina Heim |
Correspondent | Martina Heim Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-01 |
Decision Date | 2019-01-18 |
Summary: | summary |