The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue (senofilcon C) Soft Contact Lens.
| Device ID | K160212 |
| 510k Number | K160212 |
| Device Name: | ACUVUE (senofilcon C) Soft Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Johnson & Johnson Vision Care, Inc. 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256 |
| Contact | Ramona Haile |
| Correspondent | Ramona Haile Johnson & Johnson Vision Care, Inc. 7500 Centurion Parkway, 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 | 2016-01-29 |
| Decision Date | 2016-03-28 |
| Summary: | summary |