The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch + Lomb Procomfort (samfilcon A) Contact Lens, Bausch + Lomb Procomfort (samfilcon A) Contact Lens For Presbyopia,.
| Device ID | K131208 |
| 510k Number | K131208 |
| Device Name: | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Barbara Klube-falso |
| Correspondent | Barbara Klube-falso 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 | 2013-04-29 |
| Decision Date | 2013-09-11 |
| Summary: | summary |