FDA Status

Is Aurelène FDA Approved?

When it comes to purchasing skincare devices, safety and regulatory approval are top concerns for many consumers. One of the most frequently asked questions about Aurelène products is whether they are FDA approved. Let's clarify this for you.

1. Aurelène Red Light Therapy Devices - Manufactured by FDA Registered Suppliers

While not all Aurelène products require FDA approval, we prioritize your safety and well-being. Our red light therapy devices, including the popular red light therapy face mask, fall under the classification of "LAMP, INFRARED, THERAPEUTIC HEATING," which is categorized as a Class II medical device. Here are the specifics:
  • Classification Name: LAMP, INFRARED, THERAPEUTIC HEATING
  • Product Code: ILY
  • Device Class: 2
  • Proprietary Name: LED FACE MASK; LED Therapy Light
As a Class II device, these products are considered low-risk and do not require a 510(k) number for marketing. However, Aurelène chooses to work with FDA-registered manufacturers to ensure that our devices are produced under stringent quality control standards. This commitment guarantees that you receive high-quality, safe, and effective products.

2. Commitment to Quality and Safety

At Aurelène, we believe that confidence and self-care go hand in hand. Our mission is to bring that feel-good glow to women around the world through innovative skincare solutions. Whether you’re looking to banish breakouts, smooth wrinkles, or simply give your skin some extra love, our products are designed to work effectively—backed by science and powered by care.We take your safety seriously. By partnering with manufacturers that adhere to FDA regulations, we ensure that our red light therapy devices meet the highest standards of effectiveness and safety for consumer use.


In summary, while our red light therapy devices may not require specific FDA approval, they are manufactured by FDA-registered suppliers who adhere to rigorous quality control standards. At Aurelène, we are committed to providing you with effective skincare solutions that you can trust