The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Boston Simplusmulti-action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner.
| Device ID | K181627 |
| 510k Number | K181627 |
| Device Name: | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Melissa Thomas |
| Correspondent | Melissa Thomas Bausch & 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 | 2018-06-20 |
| Decision Date | 2018-08-10 |
| Summary: | summary |