The following data is part of a premarket notification filed by Bausch + Lomb Incorporated with the FDA for Boston Xo (hexafocon A), Boston Xo2 (hexafocon B).
| Device ID | K171404 |
| 510k Number | K171404 |
| Device Name: | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BAUSCH + LOMB Incorporated 1400 North Goodman Street Rochester Ny, NY 14609 |
| Contact | Glenn A. Davies |
| Correspondent | Ellen M. Beucler Foresight Regulatory Strategies, Inc 187 Ballardvale Street, Suite A250 Wilmington, MA 01887 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-12 |
| Decision Date | 2017-07-17 |
| Summary: | summary |