510(k) K181796
K181796 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions". The FDA issued a decision of Substantially Equivalent on Aug 3, 2018. 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 89 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2018
- Date Received
- Jul 5, 2018
- 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
- 510(k)