FDA 510(k)

VitreOx Anti-fog Solution

K-Number: K163257 · 2017-05-24

Decision Date2017-05-24

Product CodeOCT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

VitreOx Anti-fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sio2 Nanotech, LLC. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K163257. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitreOx Anti-fog Solution?

VitreOx Anti-fog Solution is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Sio2 Nanotech, LLC. The 510(k) number is K163257.

When did VitreOx Anti-fog Solution receive FDA 510(k) clearance?

VitreOx Anti-fog Solution received FDA 510(k) clearance on 2017-05-24, under 510(k) number K163257.

Who is the listed applicant for VitreOx Anti-fog Solution?

The FDA 510(k) record lists Sio2 Nanotech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitreOx Anti-fog Solution?

The FDA product code for VitreOx Anti-fog Solution is OCT.

Related Devices (Code: OCT)

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.

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K221293E-Brik Visualization AssistantJdi Surgical, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K152948Medline Anti-Fog SolutionMedline Industries, 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.