The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Soflens One Day Disposable (hilafilcon A) Visibility Tinted Contact.
| Device ID | K011718 |
| 510k Number | K011718 |
| Device Name: | BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT |
| Classification | Lens, Contact, (disposable) |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Contact | Debra Ketchum |
| Correspondent | Debra Ketchum BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-07-25 |
| Summary: | summary |