SANHE JUMEI TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Sanhe Hebei, CN · Registration 3031233197

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
3031233197
FEI Number
3031233197
Entity Name
SANHE JUMEI TECHNOLOGY CO.,LTD
City/State/Country
Sanhe Hebei, CN
Establishment Address
001, 1002, 1003, Building A1, Modern Service Industrial Park, Sanhe Hebei 065200, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Sanhe Jumei Technology Co.,Ltd (Owner Number: 10090547)
Owner / Operator Contact Address
001, 1002, 1003, Building A1, Modern Service Industrial Park, Sanhe, CN-HE 065200, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242186
PMA Number
N/A

All Registered Proprietary Names

Powered microneedle device,Z709,Z720,W780 Lipo Laser System,W100C,W180,W180A Q-Switched Nd:YAG Laser System,Z150,Z150pro Hydrogen Oxygen Small Bubble System,Z400 CO2 Fractional Laser System,Z121,Z131,Z131pro,Z190,Z190A; Roller Beauty System,Z710 Shock Wave System,W970 CO2 Laser Therapy Systems,Z131,Z131Pro,Z100,Z121,Z190,Z190A Picosecond/ ND:YAG Laser Tattoo Removal & Pigmentation Removal System, Z170Pro,Z150MAX ,Z170,Z170A,Z170B,Z180 Powered Muscle Stimulator,Z950,Z900,Z940,Z940Pro,W960A,W970

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2025-12-24
ORK Laser Assisted Lipolysis General, Plastic Surgery Class 2 878.4810 2025-12-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-20
NXF Gas, Laser Generating General, Plastic Surgery Class 1 878.4810 2025-12-24
KJB Apparatus, Roller Hematology Class 1 864.2240 2025-12-24
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2025-12-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-05-21
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2024-05-21
QHF Energy Based Device For Treatment Of Tattoos General, Plastic Surgery Class 2 878.4810 2025-12-24
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-02-24

Official Correspondent

No official correspondent registered.

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

Sanhe Jumei 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 3031233197. Last updated year: 2026. Please use registration number 3031233197 when referencing this establishment in official correspondence.
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