The following data is part of a premarket notification filed by Bausch + Lomb, Incorporated with the FDA for Bausch + Lomb (kalifilcon A) Soft Contact Lens, Bausch + Lomb (kalifilcon A) Soft Contact Lens For Astigmatism.
| Device ID | K200528 |
| 510k Number | K200528 |
| Device Name: | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens For Astigmatism |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Bausch + Lomb, Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Contact | Barbara Klube-falso |
| Correspondent | Barbara Klube-falso Bausch + Lomb, Incorporated 1400 North Goodman Street Rochester, NY 14609 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-06-02 |