Plasma Pen (Plasma MD); Plasma Pen (Plasma +)— 510(k) K223440

Substantially Equivalent

Plasma Concepts

FDA 510(k) clearance K223440 for Plasma Pen (Plasma MD); Plasma Pen (Plasma +), Substantially Equivalent on 2023-03-02. Applicant: Plasma Concepts. Device class: 2.

Clearance details

Applicant
Plasma Concepts
Product code
Code QVJ
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Woburn, MA, US
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