Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

FDA is recognized by most countries

l United States: FDA certification is a basic requirement for selling food, drugs, medical devices and other products in the U.S. market.

l Canada: Canada generally accepts FDA certification as an important mark to prove product quality and compliance.

l Europe: Although Europe has its own CE certification system, FDA certification is often seen as an additional advantage because it represents that the product meets high standards and helps gain recognition in the European market.

l Asia: Asian countries including China, Japan, South Korea and other countries usually accept FDA certified products, especially medical devices and drugs.

l South America: Many South American countries also recognize FDA certification and regard it as a guarantee of product quality.

Classification of Medical Devices

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and /or user and Class III devices pose the highest risk.

Sunsred is FDA Class II registered 

Sunsred is a professional manufacturer focus on red light therapy (RLT) products, belongs to medical devices, we are FDA class II registered.

Normally, clients can check FDA registration information via below link, just type the owner/operator code and search then you can the result.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

If any further questions please contact our sales director via savannah@sunsred.com, thank you.