510(k) K201013
K201013 is an FDA 510(k) premarket notification submitted by Optixon, Inc. for the device "Optixon 1-Day". The FDA issued a decision of Substantially Equivalent on Sep 18, 2020. 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
- Sep 18, 2020
- Date Received
- Apr 17, 2020
- 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)