The following data is part of a premarket notification filed by Bausch And Lomb Incorporated with the FDA for Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution.
| Device ID | K180319 |
| 510k Number | K180319 |
| Device Name: | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | Bausch And Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Melissa Thomas |
| Correspondent | Melissa Thomas Bausch And Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-05 |
| Decision Date | 2018-03-27 |
| Summary: | summary |