The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Crystalsert Delivery System.
| Device ID | K132593 |
| 510k Number | K132593 |
| Device Name: | CRYSTALSERT DELIVERY SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | BAUSCH & LOMB 30 ENTERPRISE, SUITE 450 Aliso Viejo, CA 92656 -7115 |
| Contact | Yi Gao |
| Correspondent | Yi Gao BAUSCH & LOMB 30 ENTERPRISE, SUITE 450 Aliso Viejo, CA 92656 -7115 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-19 |
| Decision Date | 2013-09-17 |
| Summary: | summary |