510(k) K160212
K160212 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE (senofilcon C) Soft Contact Lens". The FDA issued a decision of Substantially Equivalent on March 28, 2016. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Johnson & Johnson Vision Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2016
- Date Received
- January 29, 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