K-number	K230586
Device name	Renuvion® Micro Handpiece
Applicant	Apyx Medical Corporation
Product code	GEI
Device class	Class II
Decision date	Jun 9, 2023
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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Renuvion® Micro Handpiece

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