Name: Predicase
Price: 199 USD

K-number	K211652
Device name	Renuvion Dermal Handpiece, Renuvion Dermal System
Applicant	Apyx Medical Corporation (Formerly Bovie Medical Corporation
Product code	GEI
Device class	Class II
Decision date	May 25, 2022
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Renuvion Dermal Handpiece, Renuvion Dermal System

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