The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear And Tinted (visibility And/or Cosmetically).
| Device ID | K062614 |
| 510k Number | K062614 |
| Device Name: | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Contact | Susan Morris |
| Correspondent | Susan Morris 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2006-11-01 |
| Summary: | summary |