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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K261370
Device Name LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
Applicant
Guangdong Newdermo Biotech Co., Ltd.
Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village, Shiqi Town,
Guangzhou,  CN 511450
Applicant Contact JunYi Xing
Correspondent
Guangdong Newdermo Biotech Co., Ltd.
Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village, Shiqi Town,
Guangzhou,  CN 511450
Correspondent Contact JunYi Xing
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Codes
OHS   OLP  
Date Received04/27/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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