The following data is part of a premarket notification filed by Circuit Tree with the FDA for The Wave Digital Phaco System.
| Device ID | K981989 |
| 510k Number | K981989 |
| Device Name: | THE WAVE DIGITAL PHACO SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | CIRCUIT TREE 25707N COMPASS WAY San Juan Capistrano, CA 92675 |
| Contact | Maurice Imonti |
| Correspondent | Maurice Imonti CIRCUIT TREE 25707N COMPASS WAY San Juan Capistrano, CA 92675 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-05 |
| Decision Date | 1998-08-25 |