The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Biotrue Oneday With Naturmoist, Biotrue Oneday For Presbyopia With Naturmoist, Biotrue Oneday For Astigmatism With Naturmoist.
| Device ID | K151918 |
| 510k Number | K151918 |
| Device Name: | Biotrue ONEday With NaturMoist, Biotrue ONEday For Presbyopia With NaturMoist, Biotrue ONEday For Astigmatism With NaturMoist |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB INCORPORATED 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Barbara Klube-falso |
| Correspondent | Barbara Klube-falso BAUSCH & LOMB INCORPORATED 1400 North Goodman Street 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 | 2015-07-13 |
| Decision Date | 2016-02-11 |
| Summary: | summary |