Vivaer ARC Stylus
K-Number: K172529 · 2017-12-05
ApplicantAerin Medical, Inc.
Decision Date2017-12-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Vivaer ARC Stylus is a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2017-12-05 under approval number K172529. 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 ARC Stylus?
Vivaer ARC Stylus is a medical device that received FDA 510(k) clearance on 2017-12-05. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K172529.
When was Vivaer ARC Stylus approved by the FDA?
Vivaer ARC Stylus received FDA 510(k) clearance on 2017-12-05, under approval number K172529.
What company makes Vivaer ARC Stylus?
Vivaer ARC Stylus is manufactured by Aerin Medical, Inc..
What is the FDA product code for Vivaer ARC Stylus?
The FDA product code for Vivaer ARC Stylus is GEI.
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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.