The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Nesofilcon A Contact Lens.
Device ID | K113703 |
510k Number | K113703 |
Device Name: | BAUSCH + LOMB NESOFILCON A CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
Contact | Barbara Klube-falso |
Correspondent | Barbara Klube-falso BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-16 |
Decision Date | 2012-06-05 |
Summary: | summary |