Name: Predicase
Price: 199 USD

K-number	K191484
Device name	Renuvion/J-Plasma Precise Handpiece
Applicant	Apyx Medical Corporation(Formerly Bovie Medical Corporation)
Product code	GEI
Device class	Class II
Decision date	Jul 30, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Renuvion/J-Plasma Precise Handpiece

Everything you need for a 510(k) submission. Nothing you don't.