The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue (senofilcon A) Soft Contact Lens Multifocal.
Device ID | K200243 |
510k Number | K200243 |
Device Name: | ACUVUE (senofilcon A) Soft Contact Lens Multifocal |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | Johnson & Johnson Vision Care, Inc. 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256 |
Contact | Scott Durland |
Correspondent | Scott Durland 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 | 2020-01-31 |
Decision Date | 2020-03-17 |