Atlas FDA

EVA NEXUS Ophthalmic Surgical System

FDA 510(k) clearance K213467 · decided 2022-06-14

Clearance details

K-number
K213467
Device name
EVA NEXUS Ophthalmic Surgical System
Applicant
D.O.R.C. Dutch Ophthalmic Research Center (International)
Decision
Substantially Equivalent
Date received
2021-10-28
Decision date
2022-06-14
Days to decision
229 days
Clearance type
Traditional
Product code
HQC
Device class
2
Regulation number
886.4670
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Zuidland, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01 recall (Z-2322-2026)D.O.R.C. Dutch Opthalmic Research Center Intl B.V.2026-06-05
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01 recall (Z-2323-2026)D.O.R.C. Dutch Opthalmic Research Center Intl B.V.2026-06-05
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01 recall (Z-2324-2026)D.O.R.C. Dutch Opthalmic Research Center Intl B.V.2026-06-05
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) recall (Z-1331-2024)D.O.R.C. Dutch Opthalmic Research Center Intl B.V.2024-03-21
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) recall (Z-1332-2024)D.O.R.C. Dutch Opthalmic Research Center Intl B.V.2024-03-21
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) recall (Z-1333-2024)D.O.R.C. Dutch Opthalmic Research Center Intl B.V.2024-03-21