The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Boston One Step Liquid Enzymatic Cleaner.
| Device ID | K200416 |
| 510k Number | K200416 |
| Device Name: | Boston One Step Liquid Enzymatic Cleaner |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | Bausch & Lomb Incorporated 400 Somerset Corporate Boulevard Bridgewater, NJ 08807 |
| Contact | Pinal Shah |
| Correspondent | Pinal Shah Bausch & Lomb Incorporated 400 Somerset Corporate Boulevard Bridgewater, NJ 08807 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2020-09-23 |