Class Class II

Medical Picosecond ND: YAG Laser System (PZ-6) (K250041)

K250041 2025-05-14 Traditional
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Description

Medical Picosecond ND: YAG Laser System (PZ-6) 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) NumberK250041
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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Predicate lineage for K250041

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 Picosecond ND: YAG Laser System (PZ-6) (K250041) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.2024
K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.2022
K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology C...2020

Trace the full predicate network for K250041

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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