510(k) K190045
K190045 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives". The FDA issued a decision of Substantially Equivalent on February 6, 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
- February 6, 2019
- Date Received
- January 9, 2019
- Clearance Type
- Special
- 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