Apyx Medical Gets FDA Clearance for Renuvion Micro Handpiece
14 6월 2023 - 9:25PM
Dow Jones News
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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