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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 K240282
Device Name IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd
Rm. 801, Bldg. 3, #3 Kuiqiao Rd.,
Puxin Lake, Tangxia Town
Dongguan,  CN 523719
Applicant Contact Jinlong Li
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.,Lt
Rm. 1407, Jingting Bldg., Dongzhou Community,
Guangming St., Guangming
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number878.4810
Classification Product Code
OHT  
Date Received02/01/2024
Decision Date 04/03/2024
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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