The following data is part of a premarket notification filed by Vistakon, Johnson & Johnson Vision Products, Inc. with the FDA for Vistakon (genfilcon A) Contact Lens, Clear And With Visibiliity Tint.
| Device ID | K964612 |
| 510k Number | K964612 |
| Device Name: | VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 4500 SALISBURY ROAD, SUITE 300 Jacksonville, FL 32216 |
| Contact | Susan L Walton |
| Correspondent | Susan L Walton VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 4500 SALISBURY ROAD, 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 | 1996-11-18 |
| Decision Date | 1997-01-30 |
| Summary: | summary |