FDA 510(k) Application Details - K241835

Device Classification Name

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510(K) Number K241835
Device Name AirSculpt Body Contouring System (AIRS-1-SYS)
Applicant Cellmyx
6352 Corte Del Abeto
Suite A
Carlsbad, CA 92011 US
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Contact Greg Miles
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Regulation Number

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Classification Product Code QPB
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Date Received 06/25/2024
Decision Date 11/27/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241835


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