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FDA 510(k)

SOLIX

K-Number: K222166 · 2022-11-09

ApplicantOptovue, Inc.
Decision Date2022-11-09
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLIX is a medical device manufactured by Optovue, Inc.. It received FDA 510(k) clearance on 2022-11-09 under approval number K222166. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLIX?

SOLIX is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Optovue, Inc.. The 510(k) number is K222166.

When was SOLIX approved by the FDA?

SOLIX received FDA 510(k) clearance on 2022-11-09, under approval number K222166.

What company makes SOLIX?

SOLIX is manufactured by Optovue, Inc..

What is the FDA product code for SOLIX?

The FDA product code for SOLIX is OBO.

Other Devices by Optovue, Inc.

K153080RTVue XR OCT Avanti with AngioVue Software K163475iVue K180660Avanti

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K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

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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