510(k) K161931
K161931 is an FDA 510(k) premarket notification submitted by Polydev , Ltd. for the device "Toricolors (hioxifilcon D) Soft Contact Lenses". The FDA issued a decision of Substantially Equivalent on Oct 12, 2016. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Polydev , Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2016
- Date Received
- Jul 14, 2016
- 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)