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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 K251944
Device Name Lipocosm Harmonic System
Applicant
Lipocosm, LLC
580 Crandon Blvd. Suite 201
Key Biscayne,  FL  33149
Applicant Contact Ercan Dilsen
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DE  20001
Correspondent Contact Margeaux Rogers
Regulation Number878.5040
Classification Product Code
QPB  
Date Received06/24/2025
Decision Date 06/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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