FDA device listing
AIM 50,AIM LED,CoolSpot II,EPIC LED,Gleamer,Medichoice MEDC LED,Medichoice MEDC Outpatient,Medichoice Super Exam…
FDA device listing 1142077389 · Burton Medical LLC
Key facts
| Proprietary names | AIM 50,AIM LED,CoolSpot II,EPIC LED,Gleamer,Medichoice MEDC LED,Medichoice MEDC Outpatient,Medichoice Super Exam 50,Medichoice Super Exam 50 LED,Nova Exam LED,OPLED,Outpatient II,SELED,Super Bright Spot,Super Bright Spot LED (SBL),Super Exam 50,Super Exam 50 LED |
|---|---|
| Owner/operator | Burton Medical LLC |
| Owner/operator number | 10040558 |
| Product codes | KZF |
| Device names | KZF - Device, Medical Examination, Ac Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6320 |
| Review panels | General Hospital |
| Registered establishments | Burton Medical LLC |
| Establishment registrations | 3009542956 |
| FEI numbers | 3009542956 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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