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FDA 510(k)

VivAer Stylus

K-Number: K200300 · 2020-04-13

ApplicantAerin Medical, Inc.
Decision Date2020-04-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VivAer Stylus is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2020-04-13 under 510(k) number K200300. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VivAer Stylus?

VivAer Stylus is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K200300.

When did VivAer Stylus receive FDA 510(k) clearance?

VivAer Stylus received FDA 510(k) clearance on 2020-04-13, under 510(k) number K200300.

Who is the listed applicant for VivAer Stylus?

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

What is the FDA product code for VivAer Stylus?

The FDA product code for VivAer Stylus is GEI.

Related Clinical Trials

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.

NCT07574918Measuring Nasal Airway Changes After VivAer Treatment Using AI AnalysisNOT_YET_RECRUITING

Other records listing Aerin Medical, Inc. as applicant

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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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