Class Class II

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) (K251339)

K251339 2025-07-25 Traditional
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Description

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) by Zhengzhou PZ Laser Slim Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251339
Clearance Date2025-07-25
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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Predicate lineage for K251339

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) (K251339) cites 4 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology C...2021
K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.2016
K141973DIODE LASER HAIR REMOVAL SYSTEMBeijing Anchorfree Technology Co., ...2014
K140009SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORMAlma Lasers , Ltd.2014

Trace the full predicate network for K251339

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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