The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Maxsight (polymacon) Sport-tinted Contact Lens.
| Device ID | K050157 |
| 510k Number | K050157 |
| Device Name: | MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB, INC. 1400 N. GOODMAN STREET Rochester, NY 14609 |
| Contact | Lisa Graney |
| Correspondent | Lisa Graney BAUSCH & LOMB, INC. 1400 N. GOODMAN STREET Rochester, NY 14609 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-25 |
| Decision Date | 2005-04-26 |
| Summary: | summary |