510(k) K203060
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control by
Johnson & Johnson Surgical Vision, Inc.
— Product Code HQC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2021
- Date Received
- October 8, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type