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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 K231910
Device Name DermRays Revive
Applicant
Wuhan Lotuxs Technology Co., Ltd.
501/E2, #999 High-Tech Ave.
Wuhan,  CN 430206
Applicant Contact Na Wu
Correspondent
Wuhan Lotuxs Technology Co., Ltd.
501/E2, #999 High-Tech Ave.
Wuhan,  CN 430206
Correspondent Contact Na Wu
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
OHS   OHT  
Date Received06/29/2023
Decision Date 01/30/2024
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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