Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBurton Medical, LLC
US
Last updated May 24, 2026
What Burton Medical, LLC makes
Burton Medical, LLC produces operating room light systems designed for surgical environments, including models such as the AIM 100 and AIM 200 series, as well as the APEX system. These devices are intended to provide adjustable illumination for precision medical procedures.
The company’s operating room light systems are classified as Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Burton Medical, LLC manufacture?
Burton Medical, LLC specializes in operating room light systems. These devices, such as the AIM 100, AIM 200, and APEX series, are engineered to provide adjustable lighting solutions tailored for surgical environments, ensuring optimal visibility during medical procedures.
Where is Burton Medical, LLC based?
Burton Medical, LLC is headquartered in the United States. The company’s location aligns with regulatory frameworks governing medical device manufacturing and distribution in North America.
Which regulatory registries list Burton Medical, LLC’s devices?
Burton Medical, LLC’s operating room light systems are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify specific devices like the AIM 100, AIM 200, and APEX models for regulatory and compliance purposes.
How are Burton Medical, LLC’s devices classified under FDA regulations?
Burton Medical, LLC’s operating room light systems fall under Class II classification according to FDA guidelines. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 081056859
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aim 200 | A200 | FDA UDI | Class II | Active |
| Apex | APXDC10 | FDA UDI | Class II | Active |
| Apex | APXSC8 | FDA UDI | Class II | Active |
| Aim 100 | A100SC | FDA UDI | Class II | Active |
| Aim 100 | SLW-068055-3WG | FDA UDI | Class II | Active |
| Aim 200 | A200W | FDA UDI | Class II | Active |
| Aim 100 | LGHT7303 | FDA UDI | Class II | Active |
| Aim 200 | A200FL | FDA UDI | Class II | Active |
| Aim 100 | LGHT7302 | FDA UDI | Class II | Active |
| Aim 200 | A200DC | FDA UDI | Class II | Active |
| Aim 100 | A100FL | FDA UDI | Class II | Active |
| Aim 100 | LGHT7300 | FDA UDI | Class II | Active |
| Apex | APDC8 | FDA UDI | Class II | Active |
| Aim 100 | A100DC | FDA UDI | Class II | Active |
| Aim 200 | A200SC | FDA UDI | Class II | Active |
| Apex | APEX | FDA UDI | Class II | Active |
| Aim 200 | SLW-068055-3WG | FDA UDI | Class II | Active |
| Aim 100 | LGHT7301 | FDA UDI | Class II | Active |
| Aim 100 | A100W | FDA UDI | Class II | Active |
| Aim 100 | LGHT73XX | FDA UDI | Class II | Active |
| Aim 100 | A100 | FDA UDI | Class II | Active |
| Apex | APXSC10 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.