The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens.
| Device ID | K112192 |
| 510k Number | K112192 |
| Device Name: | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Tricia Garrett |
| Correspondent | Tricia Garrett BAUSCH & LOMB, INC. 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 | 2011-07-29 |
| Decision Date | 2011-10-25 |
| Summary: | summary |