The following data is part of a premarket notification filed by Vistakon with the FDA for Acuvue Brand (etafilcon A) Soft (hydrophilic) Contact Lenses; Clear And Tinted (visibility And/or Cosmetic) With Uv Bloc.
| Device ID | K013973 |
| 510k Number | K013973 |
| Device Name: | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Contact | James W Parziale |
| Correspondent | James W Parziale VISTAKON 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 | 2001-12-03 |
| Decision Date | 2002-02-26 |
| Summary: | summary |