Apyx Plasma/RF Handpiece is available in three configurations, handpiece with twin port tip and either a 27cm or 15cm long shaft, handpiece with a single port tip and 15cm long shaft
US-based medical devices manufacturer Apyx Medical announced that the US Food and Drug Administration (FDA) has granted 510(k) approval for the Apyx Plasma/RF Handpiece, a new product in the Renuvion family.
Apyx is engaged in developing Helium Plasma Technology, marketed as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market.
Apyx Medical Corporation chief executive officer Charlie Goodwin said: “Apyx Medical Corporation is pleased to announce FDA 510(k) clearance of the Apyx Plasma/RF Handpiece, the latest addition to our Renuvion product family.
“The Apyx Plasma/RF Handpiece is designed specifically for subdermal coagulation and features important enhancements to meet the needs of our surgeon customers in the cosmetic surgery market. During the product development process, we obtained extensive feedback and input from our surgeon customers, as well as the distinguished plastic and cosmetic surgeons on our Medical Advisory Board.”
Apyx Plasma/RF Handpiece is available in three configurations
The US FDA has approved its Apyx Plasma/RF Handpiece as a sterile, single use electrosurgical device indicated for use in combination with compatible generators for the percutaneous delivery of radiofrequency energy or helium plasma for cutting, coagulation and ablation of soft tissue.
The device has been developed with enhanced features compared to its prior generations, comprising a smaller diameter instrument shaft, bullet-shaped instrument tip, and a new handle design with improved ergonomics.
The bullet-shaped instrument tip has been designed to direct the flow of plasma energy from ports on the side of the instrument tip, instead of the front of the instrument tip.
The company is rolling out the device in three configurations, handpiece with twin port tip and either a 27cm or 15cm long shaft, handpiece with a single port tip and 15cm long shaft.
The three variants of Apyx Plasma/RF Handpiece are expected to help minimise unwanted energy application near the incision entry site.
The devices features distance indicators on the tip and are intended to be sold with related epidermal marking templates to help surgeons determine the proximity of the device tip to the entry of the insertion site.
Goodwin added: “We are proud of this robust product development process, and look forward to initiating a limited commercial launch of the Apyx Plasma/RF Handpiece during the fourth quarter of 2019.”