FDA 510(k)

Diode laser Treatment System (K18)

Número K: K241498 · 2024-11-18

RequerenteHebei Keylaser Sci-Tech Co.,Ltd

Data da decisão2024-11-18

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diode laser Treatment System (K18) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Keylaser Sci-Tech Co.,Ltd. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K241498. 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.

Perguntas frequentes

What is the Diode laser Treatment System (K18)?

Diode laser Treatment System (K18) is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Hebei Keylaser Sci-Tech Co.,Ltd. The 510(k) number is K241498.

When did Diode laser Treatment System (K18) receive FDA 510(k) clearance?

Diode laser Treatment System (K18) received FDA 510(k) clearance on 2024-11-18, under 510(k) number K241498.

Who is the listed applicant for Diode laser Treatment System (K18)?

The FDA 510(k) record lists Hebei Keylaser Sci-Tech Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode laser Treatment System (K18)?

The FDA product code for Diode laser Treatment System (K18) is GEX. This falls under the Gastroenterology category.

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