The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Vistakon (narafilcon B) Contact Lens Visibility Tinted With Uv Blocker.
| Device ID | K100349 |
| 510k Number | K100349 |
| Device Name: | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Contact | Catherine Dillon |
| Correspondent | Catherine Dillon JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-05-21 |
| Summary: | summary |