ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD

FDA Device Registration & Listing · Zhengzhou City Henan, CN · Registration 3013613043

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013613043
FEI Number
3013613043
Entity Name
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD
City/State/Country
Zhengzhou City Henan, CN
Establishment Address
3rd Floor, Building 1, No. 101 Jinbai Road, High-tech Development Zone, Zhengzhou City Henan 450001, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Zhengzhou PZ Laser Slim Technology Co., Ltd (Owner Number: 10056325)
Owner / Operator Contact Address
3rd Floor, Building 1, No.101 Jinbai Road, High-tech Development Zone, Zhengzhou City, CN-HA 450001, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Fractional CO2 Laser Machine PZ-8.5A Medical Picosecond ND: YAG Laser System(PZ-6, INKXTREME ULTRA) Muscle Stimulator Device (PZ-100, GENESIS) Diode Laser Hair Removal Device PZ-606IV Diode Laser Hair Removal Device PZ-806NVD Diode Laser Hair Removal Device PZ-806NVB Diode Laser Hair Removal Device IR LUX PRO Diode Laser Hair Removal Device PZ-806NVC Diode Laser Hair Removal Device PZ-806NVP Diode Laser Hair Removal Device PZ-806NVG Diode Laser Hair Removal Device PZ-806NVJ Diode Laser Hair Removal Device PZ-806NVL Diode Laser Hair Removal Device PZ-806NVH Diode Laser Hair Removal Device HAIRMINATOR Diode Laser Hair Removal Device PZ-806NVQ Diode Laser Hair Removal Device PZ-806NVA Diode Laser Hair Removal Device PZ-806NVE Diode Laser Hair Removal Device PZ-BDT82-01 Diode Laser Hair Removal Device PZ-806NVF Powered laser surgical instrument Diode Laser Hair Removal Device PZ-806NVM Diode Laser Hair Removal Device PZ-806NVN Diode Laser Hair Removal Device PZ-806NVK Diode Laser Hair Removal Device PZ-806NVI Diode Laser Hair Removal Device PZ-806NVO invisa-RED ELITE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-06-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-05-18
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-05-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-11-21
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2017-11-29

Official Correspondent

Jermny Li

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Zhengzhou PZ Laser Slim Technology Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013613043. Last updated year: 2026. Please use registration number 3013613043 when referencing this establishment in official correspondence.
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