VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control— 510(k) K203060
Substantially EquivalentJohnson & Johnson Surgical Vision, Inc.
FDA 510(k) clearance K203060 for VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control, Substantially Equivalent on 2021-03-12. Applicant: Johnson & Johnson Surgical Vision, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code HQC
view all- K261264 — Stellaris Elite vision enhancement system +7 more
- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- K250501 — System Sophi
- K243395 — MICOR 700 with Auto I/A
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
More clearances from Johnson & Johnson Surgical Vision, Inc.
view allAdverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K203060
K-number listed on FDA's recall record- Z-2247-2023 — VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
- Z-1005-2023 — Veritas Advanced Infusion Packs, REF: VRT-AI
- Z-0086-2023 — Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203060.
Data sourced from openFDA. This site is unofficial and independent of the FDA.