510(k) K182782
K182782 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric". The FDA issued a decision of Substantially Equivalent on January 18, 2019. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2019
- Date Received
- October 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type