The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Biotrue Oneday For Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens.
| Device ID | K143632 |
| 510k Number | K143632 |
| Device Name: | Bausch + Lomb Biotrue ONEday For Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Jessica Burger |
| Correspondent | Jessica Burger 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 | 2014-12-22 |
| Decision Date | 2015-02-13 |
| Summary: | summary |