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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K223882
Device Name Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
Applicant
Shenzhen Honpal Optoelectronic Technology Co., Ltd.
Rm. 505,Shenghui Bldg. A,Xixiang St.,Baoan District
Shenzhen,  CN 518126
Applicant Contact Wang Tianming
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.1801,#161,East Lu Jiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/27/2022
Decision Date 03/27/2023
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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