The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Bausch & Lomb Soflens Multifocal (polymacon) Visibility Tinted Contact Lens.
| Device ID | K020927 |
| 510k Number | K020927 |
| Device Name: | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB 1400 NORTH GOODMAN ST. Rochester, NY 14603 -0450 |
| Contact | Debra L. B Ketchum |
| Correspondent | Debra L. B Ketchum BAUSCH & LOMB 1400 NORTH GOODMAN ST. Rochester, NY 14603 -0450 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-21 |
| Decision Date | 2002-05-16 |
| Summary: | summary |