The following data is part of a premarket notification filed by Paradigm Medical, Inc. with the FDA for The Precisionist.
| Device ID | K900493 |
| 510k Number | K900493 |
| Device Name: | THE PRECISIONIST |
| Classification | Unit, Phacofragmentation |
| Applicant | PARADIGM MEDICAL, INC. P.O. BOX 238 Volcano, CA 95689 |
| Contact | Tom Motter |
| Correspondent | Tom Motter PARADIGM MEDICAL, INC. P.O. BOX 238 Volcano, CA 95689 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-02 |
| Decision Date | 1990-08-28 |