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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K241835
Device Name AirSculpt Body Contouring System (AIRS-1-SYS)
Applicant
Cellmyx
6352 Corte Del Abeto
Suite A
Carlsbad,  CA  92011
Applicant Contact Greg Miles
Correspondent
Cellmyx
6352 Corte Del Abeto
Suite A
Carlsbad,  CA  92011
Correspondent Contact Jacqueline Schmainda
Regulation Number878.5040
Classification Product Code
QPB  
Date Received06/25/2024
Decision Date 11/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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