10
Participants
Start Date
October 22, 2021
Primary Completion Date
August 17, 2022
Study Completion Date
August 17, 2022
Renuvion APR System
The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.
Gynecomastia Correction Surgery
Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.
West End Plastic Surgery, Washington D.C.
Lead Sponsor
Apyx Medical
INDUSTRY