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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K251398
Device Name IPL Hair Removal Device (IPL-001, IPL-002)
Applicant
Shenzhen Enmind Technology Co., Ltd.
Rm. 201, Block A, #1, Qianhai Rd. 1,
Qianhaishen Port Cooperative District
Shenzhen,  CN 518000
Applicant Contact Junfeng Wang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4810
Classification Product Code
OHT  
Date Received05/06/2025
Decision Date 10/02/2025
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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