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FDA 510(k)

Diode laser hair removal machine (QDTM-02)

K-Number: K242951 · 2025-04-28

ApplicantBeijing Nubway S&T Co., Ltd.
Decision Date2025-04-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser hair removal machine (QDTM-02) is a medical device manufactured by Beijing Nubway S&T Co., Ltd.. It received FDA 510(k) clearance on 2025-04-28 under approval number K242951. 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 machine (QDTM-02)?

Diode laser hair removal machine (QDTM-02) is a medical device that received FDA 510(k) clearance on 2025-04-28. It is manufactured by Beijing Nubway S&T Co., Ltd.. The 510(k) number is K242951.

When was Diode laser hair removal machine (QDTM-02) approved by the FDA?

Diode laser hair removal machine (QDTM-02) received FDA 510(k) clearance on 2025-04-28, under approval number K242951.

What company makes Diode laser hair removal machine (QDTM-02)?

Diode laser hair removal machine (QDTM-02) is manufactured by Beijing Nubway S&T Co., Ltd..

What is the FDA product code for Diode laser hair removal machine (QDTM-02)?

The FDA product code for Diode laser hair removal machine (QDTM-02) is GEX. This falls under the Gastroenterology category.

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Other Devices by Beijing Nubway S&T Co., Ltd.

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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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