Data / Medical devices / China / Wuhan DIMED LASER TECHNOLOGY CO., LTD.
Wuhan DIMED LASER TECHNOLOGY CO., LTD.: FDA-registered device maker in Wuhan Hubei, China, 2 510(k) clearances
Wuhan DIMED LASER TECHNOLOGY CO., LTD. is registered with the FDA (registration 3014577013) in Wuhan Hubei, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014577013
- Address
- Room 202, Factory Building No. 17, East Lake High-tech Industry Innovation Base 9 Miao Shan Avenue, MiaoShan Economic Development Zone, JiangXia, Wuhan Hubei, China, 430299
- Owner or operator
- Wuhan Dimed Laser Technology Co., Ltd. (10058330)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 25, 2018
- Registered through
- 2027
- Brand names listed
- Atlas Therapy Laser System, BERYLAS Therapy Laser System, CHERYLAS Therapy Laser System, Diowave Therapy Laser System 1-60 Watts Max., EVANLAS Therapy Laser System, HARLAS SERIES Tri-Wave Medical Laser System, HARLAS Therapy Laser System, MEDRAY Therapy Laser System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2025 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | GEX | Substantially Equivalent | Wuhan Dimed Laser Technology Co., Ltd. | accessdata.fda.gov |
| October 26, 2021 | K211977 | Medical Diode Laser Systems | GEX | Substantially Equivalent | Wuhan Dimed Laser Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Powered Laser Surgical Instrument
- All makers of Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Updated September 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.