The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Alcon Ultrachopper.
| Device ID | K091777 |
| 510k Number | K091777 |
| Device Name: | ALCON ULTRACHOPPER |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON RESEARCH, LTD. 15800 ALTON PARKWAY Irvine, CA 92618 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman ALCON RESEARCH, LTD. 15800 ALTON PARKWAY Irvine, CA 92618 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-10-20 |
| Summary: | summary |