EVA NEXUS Ophthalmic Surgical System— 510(k) K213467
Substantially EquivalentD.O.R.C. Dutch Ophthalmic Research Center (International)
FDA 510(k) clearance K213467 for EVA NEXUS Ophthalmic Surgical System, Substantially Equivalent on 2022-06-14. Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International). Device class: 2.
Clearance details
- Applicant
- D.O.R.C. Dutch Ophthalmic Research Center (International)
- 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
- Zuidland, NL
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- 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 D.O.R.C. Dutch Ophthalmic Research Center (International)
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 K213467
K-number listed on FDA's recall record- Z-2322-2026 — TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
- Z-2323-2026 — TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
- Z-2324-2026 — TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
- Z-1331-2024 — Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
- Z-1332-2024 — Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
- Z-1333-2024 — Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213467.
Data sourced from openFDA. This site is unofficial and independent of the FDA.