The following data is part of a premarket notification filed by Bausch And Lomb, Inc. with the FDA for Easy-load Lens Delivery System.
| Device ID | K161012 |
| 510k Number | K161012 |
| Device Name: | Easy-Load Lens Delivery System |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | Bausch And Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
| Contact | Joyce Zhong |
| Correspondent | Joyce Zhong Bausch And Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-07-06 |
| Summary: | summary |