The following data is part of a premarket notification filed by Allergan Medical Optics with the FDA for Amo Profinesse Iii Ultrasonic Handpiece System.
| Device ID | K951462 |
| 510k Number | K951462 |
| Device Name: | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ALLERGAN MEDICAL OPTICS 9701 JERONIMO RD. Irvine, CA 92618 -2020 |
| Contact | Jeanne Erickson |
| Correspondent | Jeanne Erickson ALLERGAN MEDICAL OPTICS 9701 JERONIMO RD. Irvine, CA 92618 -2020 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-30 |
| Decision Date | 1995-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05050474521094 | K951462 | 000 |
| 15050474520704 | K951462 | 000 |