Collection: FDA Cleared Spa Equipment

The spa equipment in this collection have all been FDA cleared.  These machines are class 2 medical devices, and the FDA deems has issued a 510K number from them, indicating they are substantially equivalent to predicate machines, which have been deemed both safe and able to deliver the promised results when used properly.

Read our disclaimer.

Please note that other spa equipment advertised and sold by Rejuva Fresh are not necessarily categorized as class 2 medical devices and  may not have been presented to the FDA for the clearance process.  Just because a spa machine in not listed in this collection doesn’t mean it’s not completely safe to use.  It just means that we didn’t consider it to practical or necessary to be presented to the FDA. 

Also please note that spa machines with medical FDA clearance will normally have a higher sale price due to the FDA clearance process being relatively expensive ($100K - $1mil+, depending on how many modalities).  However, you will still find that are prices are very reasonable compared to many other US companies.  Rejuva Fresh sells our equipment exclusively online and pass the savings onto our clients.  This also enables us to provide free personalized training and other support services to our clients for free.

The pathway for obtaining USA FDA approval for medical devices is a thorough and demanding process.

To ensure the safety and effectiveness of a device, it must undergo clinical testing, typically supervised by medical experts knowledgeable about the specific product or similar ones.

The approval process can vary in duration, but generally it takes several years to review new and innovative treatments and devices in the cosmetic industries to finalize USA medical FDA approval.