About Celluma

Celluma LED light therapy devices use specific wavelengths of light energy to improve cellular health by accelerating the repair and replenishment of compromised tissue cells for enhanced results. Originally developed by NASA for astronauts who could become injured or ill on long-term space missions, low-level-light therapy is used today as a safe and natural method of treating a variety of skin and pain conditions such as acne, wrinkles, aging skin and pain.

Celluma LED devices are FDA cleared to treat the following conditions :

• Full face wrinkles
• Inflammatory acne vulgaris
• Diminished local blood circulation
• Muscle & joint stiffness
• Muscle tissue tension
• Muscle & joint pain
• Muscle spasm
• Arthritic pain

Celluma is also CE Marked in the European Union (EU) as a Class IIa medical device for wound healing and was the first device of its kind to achieve such status.

Why FDA Cleared is Important to You?

As a Class II medical device, the Celluma SERIES of light therapy machines are FDA cleared. The FDA regulates any “medical claims” made by device manufacturers. Accordingly, before any medical claims can be legally made by a device manufacturer, those claims must be reviewed by the FDA for both efficacy and safety. The FDA does not test devices themselves, however they thoroughly analyze the data submitted by manufacturers, or “sponsors” to ensure that the claims made about the device are substantiated and that users of the products can expect effective and safe performance, relative to the claims.

Having a medical light therapy device “cleared” by the FDA is a rigorous, time-consuming and expensive process. Medical device manufacturers that pursue FDA clearance are demonstrating to the public their commitment to providing safe and effective products. Essentially, they are putting their money where their mouth is. As such, medical devices that are granted FDA clearance are made by companies who have the public interest in mind and don’t try to circumvent federal regulations in taking their products to market.

By choosing FDA cleared medical grade LED devices you are assured that appropriate regulation and authoritative oversight has been conducted. FDA clearance means that the device you are purchasing has been confirmed efficacious and safe when used as directed. In order for a medical device to receive FDA clearance, each component of the device must pass inspection – including each of its sources, suppliers, and manufacturers. Without FDA regulation, neither the device itself nor its suppliers are held accountable to quality controls or manufacturing standards, resulting in a product that may be considerably less effective and oftentimes significantly less safe than FDA cleared devices. So it stands to reason, whether choosing a red light LED device for professional or home use, whether for the treatment of skin or pain conditions, to choose a professional, medical grade light therapy device that has withstood and passed the rigorous demands of an FDA review.