The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Boston Scleral Lens Case.
| Device ID | K173365 |
| 510k Number | K173365 |
| Device Name: | Bausch + Lomb Boston Scleral Lens Case |
| Classification | Case, Contact Lens |
| Applicant | Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Nancy Fehrman |
| Correspondent | Nancy Fehrman Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-26 |
| Decision Date | 2017-11-17 |
| Summary: | summary |