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FDA 510(k)

Vitreq disposable laser probes, light fibers and Chandelier

K-Number: K182646 · 2019-05-01

ApplicantVitreQ BV
Decision Date2019-05-01
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Vitreq disposable laser probes, light fibers and Chandelier is the device name listed in this FDA 510(k) record. The listed applicant is VitreQ BV. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K182646. 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 Vitreq disposable laser probes, light fibers and Chandelier?

Vitreq disposable laser probes, light fibers and Chandelier is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is VitreQ BV. The 510(k) number is K182646.

When did Vitreq disposable laser probes, light fibers and Chandelier receive FDA 510(k) clearance?

Vitreq disposable laser probes, light fibers and Chandelier received FDA 510(k) clearance on 2019-05-01, under 510(k) number K182646.

Who is the listed applicant for Vitreq disposable laser probes, light fibers and Chandelier?

The FDA 510(k) record lists VitreQ BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitreq disposable laser probes, light fibers and Chandelier?

The FDA product code for Vitreq disposable laser probes, light fibers and Chandelier is HQB.

Other records listing VitreQ BV 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.

K202038CryoTreQ

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.

K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc.K191846MAXReach Laser ProbeVortex Surgical, Inc.

Official Source

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

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