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 Lens Clear And Visibility Tinted With Uv Blocker.
| Device ID | K994318 |
| 510k Number | K994318 |
| Device Name: | VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 CENTURION PKWY. Jacksonville, FL 32256 |
| Contact | Sharon Briggs |
| Correspondent | Sharon Briggs VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 CENTURION PKWY. 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 | 1999-12-22 |
| Decision Date | 2000-02-23 |
| Summary: | summary |