Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
K-Number: K223440 · 2023-03-02
ApplicantPlasma Concepts
Decision Date2023-03-02
Product CodeQVJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is a medical device manufactured by Plasma Concepts. It received FDA 510(k) clearance on 2023-03-02 under approval number K223440. The device is classified under product code QVJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Plasma Concepts. The 510(k) number is K223440.
When was Plasma Pen (Plasma MD); Plasma Pen (Plasma +) approved by the FDA?
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) received FDA 510(k) clearance on 2023-03-02, under approval number K223440.
What company makes Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is manufactured by Plasma Concepts.
What is the FDA product code for Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?
The FDA product code for Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is QVJ.
Related Devices (Code: QVJ)
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.