The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Soflens One Day Plus Disposable (hilafilcon B) Visibility Tinted Contact Lens.
| Device ID | K061157 |
| 510k Number | K061157 |
| Device Name: | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| Applicant | BAUSCH & LOMB 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Debra Ketchum |
| Correspondent | Debra Ketchum BAUSCH & LOMB 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-06-22 |
| Summary: | summary |