VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
FDA 510(k) clearance K203060 · decided 2021-03-12
Clearance details
- K-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
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-08
- Decision date
- 2021-03-12
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) recall (Z-2247-2023) | Johnson & Johnson Surgical Vision, Inc. | 2023-07-28 |
| Veritas Advanced Infusion Packs, REF: VRT-AI recall (Z-1005-2023) | Johnson & Johnson Surgical Vision, Inc. | 2023-01-20 |
| Veritas Advanced Infusion Packs. Used in ophthalmic procedures. recall (Z-0086-2023) | Johnson & Johnson Surgical Vision, Inc. | 2022-10-12 |