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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 K230473
Device Name IPL Hair Removal Device Models: MLY-T069
Applicant
Miley Technology (Hebei) Co., Ltd.
Bldg. 3, High Tech Industrial Zone, S. Of Xinneng
St., Economic Development Zone
Handan,  CN 057750
Applicant Contact Hualing Wang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received02/22/2023
Decision Date 06/15/2023
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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