The following data is part of a premarket notification filed by Vistakon, Johnson & Johnson Vision Products, Inc. with the FDA for Vistakon (lenefilcon A) Soft (hydrophilic) Contact Lenses, Clear And Visibility Tint, With Uv Blocker, For Daily Wear.
| Device ID | K991163 |
| 510k Number | K991163 |
| Device Name: | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 4500 SALISBURY RD. SUITE 300 Jacksonville, FL 32216 |
| Contact | Martine D Martino |
| Correspondent | Martine D Martino VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 4500 SALISBURY RD. SUITE 300 Jacksonville, FL 32216 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-07 |
| Decision Date | 1999-06-08 |
| Summary: | summary |