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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 K252618
Device Name IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
Applicant
Alovea Healthcare Co. , Ltd.
Rm. 703, Bldg. 1, # 188 Fu Chun Jiang Rd. New
District
Suzhou,  CN 215163
Applicant Contact Bingying Hou
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 Received08/19/2025
Decision Date 11/14/2025
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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