The following data is part of a premarket notification filed by Alcon Manufacturing, Ltd. with the FDA for Infiniti(r) Vision System.
| Device ID | K120912 |
| 510k Number | K120912 |
| Device Name: | INFINITI(R) VISION SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON MANUFACTURING, LTD. 15800 ALTON PKWY. Irvine, CA 92618 -3818 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman ALCON MANUFACTURING, LTD. 15800 ALTON PKWY. Irvine, CA 92618 -3818 |
| Product Code | HQC |
| Subsequent Product Code | HQR |
| Subsequent Product Code | KYB |
| Subsequent Product Code | MLZ |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-06-15 |
| Summary: | summary |