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510(k) K223262

Renuvion® APR Handpiece by Apyx Medical Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2023
Date Received
October 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Apyx Medical Corporation

  • K244050 — AYON Body Contouring System (AYON SYSTEM) (May 12, 2025)
  • K230586 — Renuvion® Micro Handpiece (June 9, 2023)
  • K230272 — Renuvion® APR Handpiece (April 27, 2023)
  • K221830 — Apyx One Console (October 11, 2022)

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