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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 K230090
Device Name Diode Laser Hair Removal
Applicant
Wuhan Lotuxs Technology Co., Ltd.
501/E2, Future City, No.999 high-tech avenue
Wuhan 430206, China(Free Trade Zone/Wuhan Area)
Wuhan,  CN 430075
Applicant Contact Na Wu
Correspondent
Tacro Guangzhou Branch
501/E2, Future city, No.999 High-Tech Avenue
(Free Trade Zone/Wuhan Area)
Wuhan,  CN 430206
Correspondent Contact Na Wu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/12/2023
Decision Date 04/19/2023
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
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