The following data is part of a premarket notification filed by Johnson & Johnson Surgical Vision, Inc. with the FDA for Veritas Phacoemulsification Console, Veritas Advanced Fluidics Pack And Advanced Infusion Pack, Veritas Swivel Handpiece, Veritas Advanced Foot Pedal, Veritas Remote Control.
| Device ID | K203060 |
| 510k Number | K203060 |
| Device Name: | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack And Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control |
| Classification | Unit, Phacofragmentation |
| Applicant | Johnson & Johnson Surgical Vision, Inc. 1700 East St. Andrew Place Santa Ana, CA 92705 |
| Contact | Amanda Houston |
| Correspondent | Amanda Houston Johnson & Johnson Surgical Vision, 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 | 2020-10-08 |
| Decision Date | 2021-03-12 |