Cleared Traditional

Renuvion? Micro Handpiece

K230586 · Apyx Medical Corporation · General & Plastic Surgery

Jun 2023

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K230586 is an FDA 510(k) clearance for the Renuvion? Micro Handpiece, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Apyx Medical Corporation (Clearwater, US). The FDA issued a Cleared decision on June 9, 2023, 99 days after receiving the submission on March 2, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K230586 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2023
Decision Date	June 09, 2023
Days to Decision	99 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).