FDA Registration
Active
🇺🇸 United States
Burton Medical LLC
Reg #: 3009542956
·
FEI: 3009542956
·
Expires 2026
Products
4
Proprietary Names
24
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Burton Medical LLC
- Registration Number
- 3009542956
- FEI Number
- 3009542956
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2300 W Windsor Ct. STE C
- City
- Addison
- State
- IL
- ZIP
- 60101
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101537
Owner / Operator
- Firm Name
- Burton Medical LLC
- Operator Number
- 10040558
- Address
- 2300 W Windsor Court, STE C
- City
- Addison
- State
- IL
- Postal Code
- 60101
- Country
- US
- Correspondent
- Parameshwaran Balasubramaniam
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2023-09-13 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2025-01-02 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2012-04-27 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2025-01-02 |
Proprietary Names
APEX LED
AIM 200, MAJOR SURGICAL LIGHT
HL70
"GENIE' SINGLE CEILING AND DOUBLE CEILING
APEX
AIM 100 MINOR SURGERY LIGHT
CoolSpot II
Outpatient II
SELED
OPLED
Super Bright Spot LED (SBL)
EPIC LED
Medichoice Super Exam 50
Super Bright Spot
Super Exam 50
AIM 50
Gleamer
Medichoice MEDC LED
Medichoice Super Exam 50 LED
Super Exam 50 LED
AIM LED
Medichoice MEDC Outpatient
Nova Exam LED
XenaLux
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device