The following data is part of a premarket notification filed by Alcon Research, Llc with the FDA for Legion System.
| Device ID | K191650 |
| 510k Number | K191650 |
| Device Name: | LEGION System |
| Classification | Unit, Phacofragmentation |
| Applicant | Alcon Research, LLC 6201 South Freeway Fort Worth, TX 76134 |
| Contact | Nickerson Hill |
| Correspondent | Nickerson Hill Alcon Research, LLC 6201 South Freeway Fort Worth, TX 76134 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-20 |
| Decision Date | 2019-11-01 |