Contacting customer support?
Customer support is very important to us, which is why we continue to provide 100% of our support in-house. In order to maintain this level of dedication, we offer our support by email, 7 days a week.
When will my order ship?
All orders are Made 100% in the USA and are built to order. Once your order ships, you will receive a confirmation email, including helpful information to track your order. Shipping times may vary due to Covid-19 and its effect on the shipping industry as a whole. All orders are shipped FOB Las Vegas NV.
Where do you ship?
We regularly ship our products nationwide.
Do I need to use eyewear?
Eye protection should be used and is recommended during red light therapy. Do not stare directly into the LEDs. If your eyes are more sensitive to light or if you take medications that have a history of causing photosensitivity, we recommend that you consult your physician before using Smart Light Therapy.
Are there any conditions that would restrict the use of the SST 28?
If you are pregnant, nursing, have seizures, a pacemaker or a defibrillator please consult your doctor before using.
FDA REGISTRATION
In 2016, the FDA determined that certain general wellness products do NOT require FDA Clearance or 510(k) Clearance. Instead, these devices are simply “registered” with the FDA as General Wellness Products. The Center for Devices and Radiological Health (CDRH) defines general wellness products as products that meet the following two factors: (1) intended for only general wellness use and (2) present a low risk to the safety of users and other persons. The new policy states that:
“CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to: registration and listing and premarket notification requirements (21 CFR Part 807); labeling requirements (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803).”
The SmartSun® Therapy Device (OvationULT) is registered under FDA 21 CFR 890.5500 REN#3010627475.
