FDA 510(k)

Diode Laser Hair Removal System (MBT-Diode Laser)

K-번호: K241642 · 2024-08-02

신청자Beijing Mega Beauty Technology Co., Ltd.

결정일2024-08-02

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Diode Laser Hair Removal System (MBT-Diode Laser) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Mega Beauty Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241642. 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.

자주 묻는 질문

What is the Diode Laser Hair Removal System (MBT-Diode Laser)?

Diode Laser Hair Removal System (MBT-Diode Laser) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Beijing Mega Beauty Technology Co., Ltd.. The 510(k) number is K241642.

When did Diode Laser Hair Removal System (MBT-Diode Laser) receive FDA 510(k) clearance?

Diode Laser Hair Removal System (MBT-Diode Laser) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241642.

Who is the listed applicant for Diode Laser Hair Removal System (MBT-Diode Laser)?

The FDA 510(k) record lists Beijing Mega Beauty 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 System (MBT-Diode Laser)?

The FDA product code for Diode Laser Hair Removal System (MBT-Diode Laser) is GEX. This falls under the Gastroenterology category.

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