FDA 510(k)

Diode Laser Therapy Device (DF-DIODE LASER-S1)

Номер K: K241547 · 2024-08-13

ЗаявительWeifang Dragonfly Electronics Technology Co., Ltd.

Дата решения2024-08-13

Код продуктаGEX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Diode Laser Therapy Device (DF-DIODE LASER-S1) is the device name listed in this FDA 510(k) record. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241547. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Diode Laser Therapy Device (DF-DIODE LASER-S1)?

Diode Laser Therapy Device (DF-DIODE LASER-S1) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. The 510(k) number is K241547.

When did Diode Laser Therapy Device (DF-DIODE LASER-S1) receive FDA 510(k) clearance?

Diode Laser Therapy Device (DF-DIODE LASER-S1) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241547.

Who is the listed applicant for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

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

What is the FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

The FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1) is GEX. This falls under the Gastroenterology category.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Официальный источник

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