SkinPen Precision System
K-Number: K202243 · 2021-04-02
ApplicantCrown Aesthetics
Decision Date2021-04-02
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SkinPen Precision System is a medical device manufactured by Crown Aesthetics. It received FDA 510(k) clearance on 2021-04-02 under approval number K202243. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SkinPen Precision System?
SkinPen Precision System is a medical device that received FDA 510(k) clearance on 2021-04-02. It is manufactured by Crown Aesthetics. The 510(k) number is K202243.
When was SkinPen Precision System approved by the FDA?
SkinPen Precision System received FDA 510(k) clearance on 2021-04-02, under approval number K202243.
What company makes SkinPen Precision System?
SkinPen Precision System is manufactured by Crown Aesthetics.
What is the FDA product code for SkinPen Precision System?
The FDA product code for SkinPen Precision System is QAI.
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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.