FDA device listing
REMY Medical Therapy Laser System
FDA device listing 1264450681 · Wuhan Dimed Laser Technology Co., Ltd.
Key facts
| Proprietary names | REMY Medical Therapy Laser System |
|---|---|
| Owner/operator | Wuhan Dimed Laser Technology Co., Ltd. |
| Owner/operator number | 10058330 |
| Product codes | GEX, ILY, PDZ |
| Device names | GEX - Powered Laser Surgical Instrument, ILY - Lamp, Infrared, Therapeutic Heating, PDZ - Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810, 890.5500 |
| Review panels | General & Plastic Surgery, Physical Medicine |
| Registered establishments | Wuhan DIMED LASER TECHNOLOGY CO., LTD. |
| Establishment registrations | 3014577013 |
| FEI numbers | 3014577013 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database