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510(k) K251944

Lipocosm Harmonic System by Lipocosm, LLC — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2026
Date Received
June 24, 2025
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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