The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Boston Equalens Ii (oprifocon A) Rigid Gas Permeable Contact Lens.
| Device ID | K022128 |
| 510k Number | K022128 |
| Device Name: | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Contact | Debra L Ketchum |
| Correspondent | Debra L Ketchum BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-01 |
| Decision Date | 2002-08-22 |
| Summary: | summary |