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 |