510(k) K191397
K191397 is an FDA 510(k) premarket notification submitted by Visco Vision, Inc. for the device "OxySoft (olifilcon C) silicone hydrogel soft contact lens". The FDA issued a decision of Substantially Equivalent on Oct 2, 2019. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Visco Vision, Inc. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 2, 2019
- Date Received
- May 24, 2019
- 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)