Medical Diode Laser Systems
Wuhan Dimed Laser Technology Co., Ltd.
Wuhan DIMED LASER TECHNOLOGY CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014577013 | 3014577013 | Wuhan DIMED LASER TECHNOLOGY CO., LTD. | 1 | N | 2026-01-01 | Room 202, Factory Building No. 17, East Lake High-tech Industry 9 Miao Shan Avenue, MiaoShan Economic Developmen Wuhan Hubei CN 430299 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 221537 | 1168952765 | 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 | 2025-09-25 |
| 221537 | 1027931892 | K211977 | Medical Diode Laser Systems | GEX | 2021-10-26 |
| 221537 | 1264450681 | ||||
| 221537 | 1309858010 | ||||
| 221537 | 2022013302 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 2 | 2025-09-25 |
PMN#
GUDID#
DIMED - CHERYLAS-15N is a Class 4 Laser products with the wavelength of 1470nm, max. output power 15W. The product code of the device is GEX, and the device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
2025-10-17
DIMED - CHERYLAS-20N is a Class 4 Laser products with the wavelength of 1470nm, max. output power 20W. The product code of the device is GEX, and the device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
2025-10-17
SIRONA - The SIRONA 100 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via flexible fiber connected at one end to the laser source and the other end to the Handpiece. The device is activated by means of a footswitch or a finger switch on the handpiece.
2025-10-16
REMY - REMY Medical Therapy Laser System with Regulation Number: 21 CFR 878.4810, is intended to use in physical therapy, Podiatry and temporary increase of clear nail in patients with onychomycosis. The 510K number is K190034.
2025-10-14
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02
Dimed - Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
2021-03-02