Burton Medical, LLC
For more than 90 years, healthcare professionals have chosen Burton lights for value, reliability, and quality. Compare, and see for yourself the noticeably brighter lights with no increase in heat, designed and manufactured by Burton. This catalog shows general descriptions and features of our surgical, magnifier, under cabinet, patient, and examination lights. We look forward to providing you with further information, specifications, pricing, or product demonstrations. Burton is a medical device manufacturer engaged in the business of designing, manufacturing, and distributing high-quality examination, and surgery lighting equipment.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Supplies
- Market Focus:
- Globally (various continents)
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
About Us
Since its inception in 1928, Burton has been known for superior quality, exceptional value, and long-lasting solutions to complex lighting issues facing physicians, surgeons, and veterinarians throughout the world. Burton has over 375,000 lights installed in the United States alone and continues to grow based on its quality, reliability, and extraordinary five-year warranty. Burton is located in Addison, Illinois, just west of Chicago.
Meeting & Exceeding Standards
Burton is certified as an ISO 13485 manufacturing facility, the global standard for medical device manufacturers. Burton’s products meet UL/IEC 60601-1, EN/IEC 60601-2-41 and CAN/CSA C22.2 NO. 601.1 M90 certified standards for the U.S. and European markets.
As an FDA-registered facility, Burton manufactures products to meet all FDA requirements, UL and CE certification standards.
Burton products are distributed worldwide through a network of company and independent sales representatives. In the U.S., Burton is a highly recognized brand offered by the premier medical product distribution companies.
Regulatory Standards
Burton is committed to providing you with the safest and more effective medical lights for all your applications. Our lights are designed and manufactured to meet all applicable regulatory requirements and our facilities are certified to the global standard for medical device manufacturing companies.
Burton is certified to the ISO 13485 standards by TÜV SÜD America.
“ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”
Burton is also registered as a medical device manufacturer by the United States Food and Drug Administration (FDA) and by Health Canada.
Companies must be registered by the FDA to manufacture medical devices in the United States. This registration requires Burton to follow the FDA Quality System Regulation.
Burton’s products are tested and certified to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-41 and CAN/CSA C22.2 NO. 60601 standards.
IEC 60601-1 is the general requirements for basic safety of medical electrical equipment. It includes requirements for electrical, mechanical, radiation and flammability hazards and also requirements for structural components, labelling and accompanying documents. This standard is applicable to all electrical medical devices.
IEC 60601-2-41 specifies the requirements for the essential performance of surgical luminaires and luminaires for diagnosis.
The products are also CE marked according to the requirements of the Medical Device Directive MDD 93/42/EEC for distribution in the European Union.
EnabLED Licensing Program
Burton Medical, LLC is part of the EnabLED Licensing program. Being an official licensee member, Burton is able to utilize EnabLED’s large and diverse array of LED Intellectual Property (Patents) in Product designs.