The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Purevision Multi-focal (balafilcon A) Visibility Tinted Contact Lens.
| Device ID | K050948 |
| 510k Number | K050948 |
| Device Name: | PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Anne Zavertnik |
| Correspondent | Anne Zavertnik BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2005-05-18 |
| Summary: | summary |