Celluma"One of the most versatile FDA-cleared LED light therapy systems available, with clearance for multiple indications spanning aesthetics and wellness."
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. Originally developed by NASA for astronauts who might become injured or ill during long-term space missions, low-level-light therapy is now used as a safe, non-invasive method for treating a variety of skin and pain conditions, including acne, wrinkles, aging skin, and pain.
Across devices and models, the following types of indications have been listed in FDA clearances or manufacturer materials :
- Acne vulgaris
- Wrinkles / aging skin
- Muscle & joint pain
- Muscle & joint stiffness
- Muscle spasm
- Arthritis / arthritic pain
- Compromised local circulation
- Hair restoration (model-specific)
- Body contouring (model-specific)
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 this status.
Why FDA Clearance Matters to You
As a Class II medical device, the Celluma series of light therapy machines is FDA-cleared. The FDA regulates any medical claims made by device manufacturers. Before a company can legally make such claims, those claims must be reviewed by the FDA for both safety and efficacy. Although the FDA does not test devices directly, it thoroughly analyzes the clinical data submitted by manufacturers, or “sponsors,” to ensure the claims are substantiated and users can expect safe and effective performance relative to the stated indications.
Obtaining FDA clearance is a rigorous, time-consuming, and costly process. Manufacturers who pursue it demonstrate a genuine commitment to providing safe and effective products—they are essentially putting their money where their mouth is. Devices that achieve FDA clearance are made by companies that prioritize public safety rather than attempting to bypass federal regulations.
By choosing an FDA-cleared, medical-grade LED device, you can trust that the product has undergone appropriate oversight and regulation. FDA clearance confirms that the device has been proven safe and effective when used as directed. Each component of the device—from parts to suppliers to manufacturers—must also meet strict standards in order for the device to be cleared. Without FDA regulation, neither the device nor its suppliers are held accountable to quality controls, which may result in a product that is less effective and potentially unsafe.
