510(k) K181656
K181656 is an FDA 510(k) premarket notification submitted by Eyemed Technologies S.R.L. for the device "ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)". The FDA issued a decision of Substantially Equivalent on Mar 5, 2019. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 5, 2019
- Date Received
- Jun 22, 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
- 510(k)