The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Bioture Oneday For Presbyopia (nesofilcon A) Contact Lens.
| Device ID | K132715 |
| 510k Number | K132715 |
| Device Name: | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Contact | Jennifer Knicley |
| Correspondent | Jennifer Knicley 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 | 2013-08-30 |
| Decision Date | 2013-12-20 |
| Summary: | summary |