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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 K252495
Device Name LSSA (NP-200)
Applicant
Newpong Co., Ltd.
#1212, #1216 Sj Technoville, 278, Beotkkot-Ro, Geumcheon-Gu
Seoul,  KR 08511
Applicant Contact JongMyung Shin
Correspondent
Newpong Co., Ltd.
4855 Shady Pines Dr.
Saint Cloud,  FL  34772
Correspondent Contact Leo W Choi
Regulation Number878.5040
Classification Product Code
QPB  
Date Received08/08/2025
Decision Date 04/03/2026
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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