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510(k) K241835

AirSculpt Body Contouring System (AIRS-1-SYS) by Cellmyx — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
June 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty For Removal
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

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