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

Name: FDA 510(k) clearance K220263
Creator: U.S. Food and Drug Administration
Published: 2022-11-03

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.. Device class: 2.

Clearance details

Applicant: Vortex Surgical, Inc.
Product code: Code HQB
Device class: Class 2
Regulation: 21 CFR 886.4690
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 ↗

Recent devices under product code HQB

view all

K191846 — MAXReach Laser Probe2019-12-23
K182646 — Vitreq disposable laser probes, light fibers and Chandelier2019-05-01
K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE2013-11-14
K122997 — 23GA CURVED ILLUMINATING LASER PROBE2013-06-26
K122905 — PEREGRINE 23GA CURVED LASER PROBE2013-04-30

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 →

Recalls naming K220263

K-number listed on FDA's recall record

Z-1245-2026 — Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25Class II·Ongoing·Vortex Surgical Inc.·20251216
Z-1246-2026 — Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327Class II·Ongoing·Vortex Surgical Inc.·20251216
Z-1004-2026 — Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;Class II·Ongoing·Vortex Surgical Inc.·20251119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220263.

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