The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue (etafilcon A) Soft Contact Lens For Presbyopia.
Device ID | K141670 |
510k Number | K141670 |
Device Name: | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA |
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 | 2014-06-23 |
Decision Date | 2014-09-18 |
Summary: | summary |