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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K221312
Device Name Diode Laser Hair Removal Device
Applicant
Guangzhou Chuang Zao Mei Technology Co., Ltd.
Dehe International A505, #2, Qixinggang Industrial Rd.
Junhe St., Baiyun District
Guangzhou,  CN 510440
Applicant Contact Karpov Aleksandr
Correspondent
Askway Innovative , Ltd.
4f, Yuehuayuan Bldg., 2008 Nanshan Ave., Nanshan St.
Nashan District
Shenzhen,  CN 518000
Correspondent Contact Asher No last name provided
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/05/2022
Decision Date 06/29/2022
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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