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 has issued 510K numbers for the producing factories, 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 not all  spa equipment advertised and sold by Rejuva Fresh are categorized as class 2 medical devices.  Furthermore, some devices we sell may not have been presented to the FDA for the clearance process for various reasons, including because they may be more appropriately classified as class 1.  Just because a spa machine is not listed in this collection doesn’t mean it’s not completely safe to use.  All of our machines use safe and effective technology and have been rigorously tested in our research laboratories.

Also please note that spa machines with medical FDA clearance and 510K will typically have a higher sale price vs others.  This is due to the FDA clearance process being relatively expensive ($100K - $1mil+, depending on how many modalities).  However, you will still find that our prices are extremely reasonable compared to many other US companies because, even though we are a US based company, our factories are in China and because we manage the supply chain from top to bottom.

Rejuva Fresh also sells our equipment exclusively online and passes these savings onto you, our customers.  This business model also enables us to provide you with high quality free personalized training and other support services, all for free.  As a result, customer to purchase high quality thoroughly researched and tested aesthetic equipment from a reputable US based company, accredited by BBB, for a reasonable price and without having to worry about warranty issues, as our warranty is supplied by our US company.

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.