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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 K260946
Device Name LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
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 Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received03/23/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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