The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Soflens(tm) One Day Disposable (hilafilcon A) Visibility Tinted Contact Lens.
| Device ID | K974780 |
| 510k Number | K974780 |
| Device Name: | SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Michael A Santalucia |
| Correspondent | Michael A Santalucia BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-03-11 |
| Summary: | summary |