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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 K253304
Device Name IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
Applicant
Dongguan Lide Electric Appliance Co., Ltd.
Bldg. 2, # 11 Yinhe Fifth Rd., Shishuikou, Qiaotou Tow
Dongguan,  CN 523528
Applicant Contact Jinfeng Xiang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Moy Meng
Regulation Number878.4810
Classification Product Code
OHT  
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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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