Apyx Medical Gets FDA Clearance for Renuvion Micro Handpiece
By Dean Seal
Apyx Medical received 510(k) clearance from the U.S. Food and Drug Administration to market the Renuvion Micro Handpiece, the latest in its line of proprietary helium plasma and radiofrequency technology products.
The Clearwater, Fla.-based company said the handpiece is cleared with an indication for the delivery of "radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue," including subcutaneous tissue, is needed.
Chief Executive Charlie Goodwin said the product was designed with the needs of cosmetic surgeons in mind.
"It complements our existing product portfolio, providing our customers with a new option to facilitate soft tissue contraction in those cases that may benefit from the use of a handpiece with a smaller profile," Goodwin said.
The company plans to have a limited commercial launch of the Renuvion Micro Handpiece in the third quarter.
Shares rose 9.7% to $7.59 in premarket trading.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
June 14, 2023 08:10 ET (12:10 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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