FDA 510(k)

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

Número K: K232117 · 2023-11-28

RequerenteWuhan Lotuxs Technology Co., Ltd.

Data da decisão2023-11-28

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232117. 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 Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K232117.

When did Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) receive FDA 510(k) clearance?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232117.

Who is the listed applicant for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

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

What is the FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

The FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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