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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K212099
Device Name Red Wave Hair Removal
Applicant
Shenzhen Accompany Technology Co., Ltd.
Unit. 375, Xiangnan Ruifeng Gradan, No. 22, Guimiao Road,
Xuefu Community, Nanshan Street, Nanshan District
Shenzhen,  CN
Applicant Contact Yourong Lai
Correspondent
Guangdong Jianda Medical Technology Co Ltd
906 Room, Longxiang Garden, Tianhe District
Guangzhou,  CN
Correspondent Contact Jett Lee
Regulation Number878.4810
Classification Product Code
ONF  
Date Received07/06/2021
Decision Date 09/24/2021
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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