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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 K262984
Device Name Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)
Applicant
Shenzhen Bway Tech Co., Ltd.
1709, Yunhua Times, Haoxiang Rd., Bogang Community, Shajing
Shenzhen,  CN 518104
Applicant Contact Xiuzhu Zhang
Correspondent
Flying Drug & Medical Compliance Service Co., Ltd.
Rm.1505, Zhenye International Business Center, Qianhai Rd.
Shenzhen,  CN 518051
Correspondent Contact Qin Wang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received08/27/2026
Decision Date 10/26/2026
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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