FDA 510(k)

Renuvion Dermal Handpiece, Renuvion Dermal System

Número K: K211652 · 2022-05-25

RequerenteApyx Medical Corporation (Formerly Bovie Medical Corporation

Data da decisão2022-05-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renuvion Dermal Handpiece, Renuvion Dermal System is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K211652. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Renuvion Dermal Handpiece, Renuvion Dermal System?

Renuvion Dermal Handpiece, Renuvion Dermal System is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K211652.

When did Renuvion Dermal Handpiece, Renuvion Dermal System receive FDA 510(k) clearance?

Renuvion Dermal Handpiece, Renuvion Dermal System received FDA 510(k) clearance on 2022-05-25, under 510(k) number K211652.

Who is the listed applicant for Renuvion Dermal Handpiece, Renuvion Dermal System?

The FDA 510(k) record lists Apyx Medical Corporation (Formerly Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System?

The FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System is GEI.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Apyx Medical Corporation (Formerly Bovie Medical Corporation como candidato(a)

K220970Renuvion APR Handpiece K202880J-Plasma Precise FLEX Handpiece K191484Renuvion/J-Plasma Precise Handpiece

Dispositivos Relacionados (Código: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.