The following data is part of a premarket notification filed by Bausch & Lomb, Incorporated with the FDA for Boston Es (enflufocon A) Rigid Gas Permeable Contact Lens; Boston Eo (enflufocon B) Rigid Gas Permeable Contact Lens; Boston Xo (hexafocon A) Rigid Gas Permeable Contact Lens; Boston Xo2 (hexafocon B) Rigid Gas Permeable Contact Lens.
| Device ID | K183167 |
| 510k Number | K183167 |
| Device Name: | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Bausch & Lomb, Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Glenn A. Davies |
| Correspondent | Bret James Andre EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-02-12 |
| Summary: | summary |