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510(k) Data Aggregation
K Number
K223882Device Name
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
Manufacturer
Shenzhen Honpal Optoelectronic Technology Co., Ltd.
Date Cleared
2023-03-27
(90 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Honpal Optoelectronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
Device Description
The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02.
The device can be used in hospitals, clinics and households.
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