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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 K232124
Device Name IPL Hair Removal, Model: W-1095, W-1098
Applicant
Shenzhen Wochuan Electronic Co., Ltd.
6th Floor Bldg. #357 3rd Area A Huayuan Xingye 1 Rd.
Fenghuang Community Fuyong St. St.
Shenzhen,  CN 518103
Applicant Contact Rebecca Jiang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4810
Classification Product Code
OHT  
Date Received07/17/2023
Decision Date 09/14/2023
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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