FDA 510(k)

AirSculpt Body Contouring System (AIRS-1-SYS)

Número K: K241835 · 2024-11-27

Data da decisão2024-11-27

Código do produtoQPB

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AirSculpt Body Contouring System (AIRS-1-SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Cellmyx. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K241835. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AirSculpt Body Contouring System (AIRS-1-SYS)?

AirSculpt Body Contouring System (AIRS-1-SYS) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Cellmyx. The 510(k) number is K241835.

When did AirSculpt Body Contouring System (AIRS-1-SYS) receive FDA 510(k) clearance?

AirSculpt Body Contouring System (AIRS-1-SYS) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K241835.

Who is the listed applicant for AirSculpt Body Contouring System (AIRS-1-SYS)?

The FDA 510(k) record lists Cellmyx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirSculpt Body Contouring System (AIRS-1-SYS)?

The FDA product code for AirSculpt Body Contouring System (AIRS-1-SYS) is QPB.

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