The following data is part of a premarket notification filed by Alcon Manufacturing, Ltd. with the FDA for Infiniti Vision System Evergreen Ii Autosert Iol Injector Handpiece.
| Device ID | K112425 |
| 510k Number | K112425 |
| Device Name: | INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE |
| 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 | 2011-08-23 |
| Decision Date | 2011-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380658176013 | K112425 | 000 |
| 00380658173012 | K112425 | 000 |