FDA Registration
Active
🇨🇳 China
Wuhan DIMED LASER TECHNOLOGY CO., LTD.
Reg #: 3014577013
·
FEI: 3014577013
·
Expires 2026
Products
3
Proprietary Names
13
Establishment Types
4
Classifications
3
Registration Details
- Registration Name
- Wuhan DIMED LASER TECHNOLOGY CO., LTD.
- Registration Number
- 3014577013
- FEI Number
- 3014577013
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1 Minzu Avenue, Wuhan East Lake High-tech Development Zone
- City
- Wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211977
Owner / Operator
- Firm Name
- Wuhan Dimed Laser Technology Co., Ltd.
- Operator Number
- 10058330
- Address
- Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building,, 327-1 Minzu Avenue, Wuhan East Lake High-tech Development Zone,
- City
- Wuhan
- State
- Hubei
- Postal Code
- 430223
- Country
- CN
- Correspondent
- Qiao Cheng
US Agent
- Business Name
- UGK-LVM UNITED INC
- Contact Name
- jimmy chen
- Address
- 6547 N Academy Blvd #2266
- City
- Co Spgs
- State
- CO
- ZIP
- 80918
- Country
- US
- [email protected]
- Phone
- 323 5104660
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2020-12-25 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2020-12-25 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-12-25 |
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.
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device