The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Boston X02 (hexafocon B) Rigid Gas Permeable Contact Lens.
| Device ID | K071266 |
| 510k Number | K071266 |
| Device Name: | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Michael A Santalucia |
| Correspondent | Michael A Santalucia BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-08-15 |
| Summary: | summary |