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FDA 510(k)

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)

K-Number: K223882 · 2023-03-27

ApplicantShenzhen Honpal Optoelectronic Technology Co., Ltd.
Decision Date2023-03-27
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is a medical device manufactured by Shenzhen Honpal Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-27 under approval number K223882. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is a medical device that received FDA 510(k) clearance on 2023-03-27. It is manufactured by Shenzhen Honpal Optoelectronic Technology Co., Ltd.. The 510(k) number is K223882.

When was Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) approved by the FDA?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) received FDA 510(k) clearance on 2023-03-27, under approval number K223882.

What company makes Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is manufactured by Shenzhen Honpal Optoelectronic Technology Co., Ltd..

What is the FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

The FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is FTC.

Related Clinical Trials

NCT06960161 Exploring the Use of Phototherapy to Improve CPAP Compliance RECRUITING NCT07532330 Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo ACTIVE_NOT_RECRUITING NCT07073430 Application Evaluation Research on the Artificial Intelligence-assisted Support System for the Diagnosis of Colorectal Tubular Adenoma Lesions RECRUITING

Related Devices (Code: FTC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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