Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038197172

FEI Number

3038197172

Entity Name

XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

5th Floor, Building 369, Baotian 1st Road, Tiegang Community, Xixiang Street, Baoan, Shenzhen Guangdong 518102, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xemis Medical Technology (Shenzhen) Co., Ltd. (Owner Number: 10093075)

Owner / Operator Contact Address

5th Floor,Building 369, Baotian 1st Road, Tiegang Community, Xixiang Street, Baoan, Shenzhen, CN-GD 518102, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243993

PMA Number

N/A

All Registered Proprietary Names

Ultrasound Therapy Workstation Photon Therapy Apparatus (model: BL-10)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2025-11-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2025-11-24
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2025-11-24
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-11-24
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2025-11-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-03-27

Official Correspondent

Cecilia Yang

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Xemis Medical Technology (Shenzhen) 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
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

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
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3010805941	BIO PROTECH YANTAI INC	Yantai Shandong, CN
3004558433	BIOWAVE CORPORATION	NORWALK, CT, US
3014315574	BRH MEDICAL LTD	Jerusalem, IL
9615033	FUJI DYNAMICS LIMITED	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038197172. Last updated year: 2026. Please use registration number 3038197172 when referencing this establishment in official correspondence.