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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 Wrinkle Reduction
510(k) Number K260202
Device Name LED Light Therapy Masks (LumiLips FAC07NA)
Applicant
Guangdong Newdermo Biotech Co., Ltd.
Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village,
Shiqi Town, Panyu District
Guangzhou,  CN 511450
Applicant Contact Jun Yi Xing
Correspondent
Guangdong Newdermo Biotech Co., Ltd.
Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village,
Shiqi Town, Panyu District
Guangzhou,  CN 511450
Correspondent Contact Jun Yi Xing
Regulation Number878.4810
Classification Product Code
OHS  
Date Received01/23/2026
Decision Date 03/23/2026
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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