The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Amo Whitestar Signature Pro Phacoemulsification System, Whitestar Signature Pro Advance Linear (four-button) Foot Pedal, Whitestar Signature Pro (wireless) Remote Control.
| Device ID | K151636 |
| 510k Number | K151636 |
| Device Name: | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control |
| Classification | Unit, Phacofragmentation |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 EAST ST. ANDREW PLACE Santa Ana, CA 92705 |
| Contact | Christine Chun |
| Correspondent | Christine Chun ABBOTT MEDICAL OPTICS INC 1700 EAST ST. ANDREW PLACE Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-17 |
| Decision Date | 2015-10-19 |
| Summary: | summary |