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Why FDA-Cleared is Important to You?
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 as substantiated and that users of the products can expect effective and safe performance, relative to the claims.
Having a medical 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 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.
Celluma devices are FDA-cleared to treat the following conditions:
- Inflammatory Acne Vulgaris
- Diminished Local Blood Circulation
- Muscle & Joint Stiffness
- Muscle Tissue Tension
- Muscle & Joint Pain
- Muscle Spasm
- Arthritic Pain