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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K253219
Device Name LeafPure-Echo (LM-LPNdA)
Applicant
Shenzhen Leaflife Technology Co., Ltd.
4f, Bldg. C, Jmd Industrial Park, # 39 Qingfeng Blvd.
Bao Long Industrial Area, Long Gang Dist.
Shenzhen,  CN 518116
Applicant Contact Qiang Cheng
Correspondent
Aestheticcert Compliance, LLC
11/F, Block A, Gaoke Innovation Centre, Guangqiao Rd.
Guangming District
Shenzhen,  CN 518000
Correspondent Contact Asher Zeng
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/29/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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