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FDA 510(k)

AirSculpt Body Contouring System (AIRS-1-SYS)

K-Number: K241835 · 2024-11-27

ApplicantCellmyx
Decision Date2024-11-27
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: QPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251944Lipocosm Harmonic SystemLipocosm, LLCK253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical CorporationK252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical CorporationK244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLCK242804PAL Aspiration SystemMicroaire Surgical Instruments, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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