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FDA 510(k)

Diode Laser Hair Removal System (MBT-Diode Laser)

K-Number: K241642 · 2024-08-02

ApplicantBeijing Mega Beauty Technology Co., Ltd.
Decision Date2024-08-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal System (MBT-Diode Laser) is a medical device manufactured by Beijing Mega Beauty Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under approval 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.

Frequently Asked Questions

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. It is manufactured by Beijing Mega Beauty Technology Co., Ltd.. The 510(k) number is K241642.

When was Diode Laser Hair Removal System (MBT-Diode Laser) approved by the FDA?

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

What company makes Diode Laser Hair Removal System (MBT-Diode Laser)?

Diode Laser Hair Removal System (MBT-Diode Laser) is manufactured by Beijing Mega Beauty Technology Co., Ltd..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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