Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006555617

FEI Number

3006555617

Entity Name

BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD

City/State/Country

Bejing Beijing, CN

Establishment Address

1-23, 10th Floor, Building 1, No.43 Xizhimen North Street, Haidian District, Bejing Beijing 100044, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Sincoheren Science and TechnologyDevelopment Co., Lt (Owner Number: 10043830)

Owner / Operator Contact Address

1-23, 10th Floor, Building 1, No.43 Xizhimen North Street, Haidian District, Bejing, CN-BJ 100044, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152898

PMA Number

N/A

All Registered Proprietary Names

Radio Frequency System IPL Therapy System CO2 Laser Therapy Systems Diode Laser Therapy Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-23
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2013-03-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-07-10
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2017-07-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-02-21

Official Correspondent

Weng Chen

US Agent Details

Cancan Huang Business: OSMUNDA TECHNOLOGY CO., LTD. Email: sunny.huang@osmundacn.com Phone: (858) 3571157

Related Public Records

Same Entity

Beijing Sincoheren Science and TechnologyDevelopment Co., Lt

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006555617. Last updated year: 2026. Please use registration number 3006555617 when referencing this establishment in official correspondence.