FDA 510(k)

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

K-Number: K251339 · 2025-07-25

ApplicantZhengzhou PZ Laser Slim Technology Co., Ltd.

Decision Date2025-07-25

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is a medical device manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under approval number K251339. 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 Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)?

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K251339.

When was Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) approved by the FDA?

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) received FDA 510(k) clearance on 2025-07-25, under approval number K251339.

What company makes Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)?

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd..

What is the FDA product code for Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)?

The FDA product code for Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is GEX. This falls under the Gastroenterology category.

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Other Devices by Zhengzhou PZ Laser Slim Technology Co., Ltd.

K180353Diode laser hair removal device K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) K250782Fractional CO2 Laser Machine K250038Muscle Stimulator Device (PZ-100) K250041Medical Picosecond ND: YAG Laser System (PZ-6)

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Official Source

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