FDA 510(k)

초저주파 UVPhototherapy 조명기(모델: HB-UPLL-01, HB-UPLL-02)

K-번호: K223882 · 2023-03-27

신청자Shenzhen Honpal Optoelectronic Technology Co., Ltd.

결정일2023-03-27

제품 코드FTC

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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

자주 묻는 질문

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. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. The 510(k) number is K223882.

When did Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) receive FDA 510(k) clearance?

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

Who is the listed applicant for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

The FDA 510(k) record lists Shenzhen Honpal Optoelectronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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초저주파 UVPhototherapy 조명기(모델: HB-UPLL-01, HB-UPLL-02)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FTC)

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