Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014577013

FEI Number

3014577013

Entity Name

Wuhan DIMED LASER TECHNOLOGY CO., LTD.

City/State/Country

Wuhan Hubei, CN

Establishment Address

Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1 Minzu Avenue, Wuhan East Lake High-tech Development Zone, Wuhan Hubei 430223, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Wuhan Dimed Laser Technology Co., Ltd. (Owner Number: 10058330)

Owner / Operator Contact Address

Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building,, 327-1 Minzu Avenue, Wuhan East Lake High-tech Development Zone,, Wuhan, CN-HB 430223, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

REMY Medical Therapy Laser System SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) Medical Diode Laser Systems Medical Diode Laser Systems-HARLAS Medical Diode Laser Systems-BERYLAS Diowave Therapy Laser System 1-60 Watts Max. REMY Medical Therapy Laser System HARLAS SERIES Tri-Wave Medical Laser System BERYLAS Therapy Laser System CHERYLAS Therapy Laser System MEDRAY Therapy Laser System HARLAS Therapy Laser System EVANLAS Therapy Laser System Atlas Therapy Laser System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2020-12-25
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2020-12-25
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-12-25
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-02-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-02-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-11-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-03
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2018-08-25

Official Correspondent

Qiao Cheng

US Agent Details

jimmy chen Business: UGK-LVM UNITED INC Email: 1841621950@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

Wuhan Dimed 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
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, 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014577013. Last updated year: 2026. Please use registration number 3014577013 when referencing this establishment in official correspondence.