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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K252888
Device Name NeoSculpt Plus
Applicant
S&M Medical Co., Ltd.
Suite 212, 249 Chuam-Ro, Buk-Gu
Gwangju,  KR 61003
Applicant Contact Young Ok Jo
Correspondent
Lighten Bridge, LLC
4408 Tortuga Ln.
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number878.4400
Classification Product Code
PBX  
Date Received09/10/2025
Decision Date 03/09/2026
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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