The following data is part of a premarket notification filed by Alcon with the FDA for Alcon Vision System.
| Device ID | K063583 |
| 510k Number | K063583 |
| Device Name: | ALCON VISION SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON 6201 SOUTH FREEWAY, R7-20 Fort Worth, TX 76134 -2099 |
| Contact | Terry J Dagnon |
| Correspondent | Terry J Dagnon ALCON 6201 SOUTH FREEWAY, R7-20 Fort Worth, TX 76134 -2099 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-30 |
| Decision Date | 2008-05-09 |
| Summary: | summary |