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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 a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2020-04-13 under approval 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. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K200300.

When was VivAer Stylus approved by the FDA?

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

What company makes VivAer Stylus?

VivAer Stylus is manufactured by Aerin Medical, Inc..

What is the FDA product code for VivAer Stylus?

The FDA product code for VivAer Stylus is GEI.

Other Devices by Aerin Medical, Inc.

K161994Aerin Medical Stylus K172529Vivaer ARC Stylus K162810InSeca ARC Stylus, Aerin Console K192471RHIN1 Stylus K221907RhinAer® Stylus (FG1393) K242630Aerin Console

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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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