Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers— 510(k) K220263

Substantially Equivalent

Vortex Surgical, Inc.

FDA 510(k) clearance K220263 for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers, Substantially Equivalent on 2022-11-03. Applicant: Vortex Surgical, Inc..

Clearance details

Applicant: Vortex Surgical, Inc.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 2022-01-31
Decision date: 2022-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterfield, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQB

product code HQB

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.