The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue Oasys (senofilcon A) With Photochromic Additive.
| Device ID | K180299 |
| 510k Number | K180299 |
| Device Name: | ACUVUE OASYS (senofilcon A) With Photochromic Additive |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Johnson & Johnson Vision Care, Inc. 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256 |
| Contact | Victoria Brennand |
| Correspondent | Victoria Brennand 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 | 2018-02-02 |
| Decision Date | 2018-04-10 |
| Summary: | summary |