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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 the device name listed in this FDA 510(k) record. The listed applicant is Vortex Surgical, Inc.. It received FDA 510(k) clearance on 2022-11-03 under 510(k) 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. The listed applicant is Vortex Surgical, Inc.. The 510(k) number is K220263.

When did Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers receive FDA 510(k) clearance?

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 510(k) number K220263.

Who is the listed applicant for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

The FDA 510(k) record lists Vortex Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Vortex Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191846MAXReach Laser Probe

Related Devices (Code: HQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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