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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 K262932
Device Name AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)
Applicant
Shenzhen Accompany Technology Co., Ltd.
25th Floor, Gaoxin Community United Headquarters Bldg., #63,
Shenzhen,  CN 518000
Applicant Contact Chan Fu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2405 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Axiu Yang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received08/21/2026
Decision Date 10/19/2026
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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