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FDA 510(k)

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

K-Number: K220263 · 2022-11-03

ApplicantVortex Surgical, Inc.
Decision Date2022-11-03
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is a medical device manufactured by Vortex Surgical, Inc.. It received FDA 510(k) clearance on 2022-11-03 under approval number K220263. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is a medical device that received FDA 510(k) clearance on 2022-11-03. It is manufactured by Vortex Surgical, Inc.. The 510(k) number is K220263.

When was Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers approved by the FDA?

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers received FDA 510(k) clearance on 2022-11-03, under approval number K220263.

What company makes Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is manufactured by Vortex Surgical, Inc..

What is the FDA product code for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

The FDA product code for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is HQB.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07592468 Intraoperative CO₂ (Carbon Dioxide) NOT_YET_RECRUITING NCT07599709 LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARS COMPLETED NCT07566507 High-Energy Laser in the Conservative Treatment of Rhizarthrosis RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED

Other Devices by Vortex Surgical, Inc.

K191846MAXReach Laser Probe

Related Devices (Code: HQB)

K191846MAXReach Laser ProbeVortex Surgical, Inc. K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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