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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.
Room 505,Shenghui Building A,Xixiang Street,Baoan District
Shenzhen,  CN 518126
Applicant Contact Wang Tianming
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.1801,No.161,East Lujiazui 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
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