The following data is part of a premarket notification filed by Visioneering Technologies, Inc. with the FDA for Naturalvue (etafilcon A) Daily Disposable Soft (hydrophilic) Contact Lenses.
| Device ID | K173086 |
| 510k Number | K173086 |
| Device Name: | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Visioneering Technologies, Inc. 10745 Westside Way Suite 200 Alpharetta, GA 30009 |
| Contact | Stephen Snowdy |
| Correspondent | Penny Northcutt REGSolutions, LLC 174 Watercolor Way Suite 103-403 Santa Rosa Beach, FL 32459 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-11-07 |
| Summary: | summary |