LED LIGHT THERAPY

Celluma Versatility

Patented, pulsed-wave technology controlled by proprietary software algorithms add to the applicability of Celluma light emitting diode therapy. With the exception of the Celluma CLEAR (emits blue and red only) for treating acne, all Celluma devices are polychromatic and deliver blue (465nm), red (640nm) and infrared (880nm) light energy simultaneously to safely treat skin, pain and hair loss easily and affordably, both in a professional setting and at home. Each wavelength is absorbed by different molecules that act as a signaling mechanism for different cellular processes. For example, some reduce inflammation and some kill acne-causing bacteria, while others enhance localized circulation. With 14 models to choose from, whether you are seeking a solution to aging skin, acneic skin, pain or hair loss, there is a Celluma model to address your concerns and budget. Most Celluma models address several conditions in a single device so be sure to choose the model that best suits your particular needs. A full description of each is available by clicking here.

FDA Cleared Versus FDA Approved?

Have you ever wondered about the difference between FDA Cleared versus FDA Approved? Read on for a full explanation. The FDA regulates all medical claims made by device manufacturers regarding their products. The Agency uses two different processes depending on comparative risk for reviewing medical claims before manufacturers are permitted to make those claims commercially.

The 510(k) Process

The 510 (k) process is intended to review devices that are better understood by the Agency and/or potentially less hazardous to patients, like the Celluma. This process is most often used to review Class II devices. This is a less burdensome review process and if the Agency concludes that the manufacturer has demonstrated that the device is substantially equivalent to a legally marketed device, the device is “cleared” for commercialization. A device being “cleared” is not reflection on the efficacy of the device, only an indication of the comparative risk in use.

The Pre-Market Approval (PMA) process

The Pre-Market Approval (PMA) process is intended for devices not as well known to the Agency and that pose a greater risk to the patient, like implantable devices. An example would be a heart stint. These types of products are considered Class III devices. A PMA is a more burdensome process and if the Agency concludes that the manufacturer’s claims are supported using this process, the device is “approved” for commercialization. As a particular Class III device becomes better known to the FDA, it may be re-classified as a Class II device, meaning any subsequent review of such devices by the Agency will be done using the 510(k) process. Again, a PMA “approval” does not denote the relative efficacy of a device, only the comparative risk of the device in use.

That said, a device “clearance” is not somehow a subordinated “rating” by the Agency in comparison to an “approval”. It is just the favorable conclusion of a different review processes used by the Agency, depending on how common and how risky the device is getting reviewed.