510(k) K150385
K150385 is an FDA 510(k) premarket notification submitted by Visioneering Technologies, Inc. for the device "NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses". The FDA issued a decision of Substantially Equivalent on Apr 30, 2015. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Visioneering Technologies, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 30, 2015
- Date Received
- Feb 18, 2015
- 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)