FDA 510(k)

AirSculpt Body Contouring System (AIRS-1-SYS)

K-Number: K241835 · 2024-11-27

Decision Date2024-11-27

Product CodeQPB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AirSculpt Body Contouring System (AIRS-1-SYS) is a medical device manufactured by Cellmyx. It received FDA 510(k) clearance on 2024-11-27 under approval 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. It is manufactured by Cellmyx. The 510(k) number is K241835.

When was AirSculpt Body Contouring System (AIRS-1-SYS) approved by the FDA?

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

What company makes AirSculpt Body Contouring System (AIRS-1-SYS)?

AirSculpt Body Contouring System (AIRS-1-SYS) is manufactured by Cellmyx.

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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Official Source

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