Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025379728

FEI Number

3025379728

Entity Name

BEIJING JONTE LASER TECHNOLOGY CO., LTD

City/State/Country

Beijing, CN

Establishment Address

9-802,Changyang Qihang International Phase III,Fangshan District,Beijing, Beijing 102400, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Beijing Jonte Laser Technology Co., Ltd (Owner Number: 10086366)

Owner / Operator Contact Address

9-802,Changyang Qihang International Phase III,Fangshan District,Beijing, Beijing, CN-BJ 102400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202257

PMA Number

N/A

All Registered Proprietary Names

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) 1060nm laser body slimming machine Dermatological Carbon Dioxide Laser Systems Nd: YAG Laser Therapy System (QN-1) Dermatological Diode Laser Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-05-08
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2024-05-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-11-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-06-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-11-03

Official Correspondent

Ying Wang

US Agent Details

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

Related Public Records

Same Entity

Beijing Jonte Laser 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
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

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, PASLT Fiber Delivery SystemSterileNon-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

Similar Registrations

Registration Number	Establishment Name	Location
3015282440	MEDICAL CABLES S.L.	Malaga, ES
3015781781	WIEMSPRO S.L	Malaga, ES
3029924973	SHENZHEN SINREL TECH LTD	Shenzhen Guangdong, CN
3013889849	Expeditors International of Washington, Inc.	Salt Lake City, UT, US
3044675848	PEPPER INTERACTIVE INC	Wilmington, DE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025379728. Last updated year: 2026. Please use registration number 3025379728 when referencing this establishment in official correspondence.