5 Series Laser Therapy System (IR 808nm & IR 975nm Bundled Modules. Both with Combined 638nm Laser System)

Yes.  Our laser device has been intentionally engineered to meet FDA Class 3R safety classification that is considered safe when handled carefully.  No safety eyewear is required to operate the laser, which is a requirement of use for Class 3b or Class 4 laser devices.  At the same time, the 5-Series lasers delivers power light levels typically reserved for only clinical settings. This is a powerful laser therapy device.  Never shine any laser directly into your eye, knowingly direct outwardly at someone or something, or in the air, even at lower classification levels.

The 5-Series laser is indicated for relief of muscle and joint pain and stiffness, arthritis pain, muscle spasms, muscle relation, and increased blood circulation.  Our library of programs and presets provide optimal settings for utilization of laser therapy technology for these indications. Note: Doctors and therapists may use these therapy systems in various ways, so it is always important to understand their recommended use if professionally provided.

Therapy times vary based on condition, method of treatment, and physical characteristics of the patient (example: melanin, i.e. skin color).  Therapy times can range from a few minutes to an hour. Research has shown that there are optimal dosages to maximize results, and consistent use of the same parameters provide better results over time. With other light therapy solutions, it can often be very confusing to understand how long to perform therapy.  That’s why, at 528i, we provide a library of programs that personally guide you through the optimal dosing parameters and therapy times to consistently meet your wellness goals.

Side effects are rare, but some users may experience temporary redness, warmth, or tingling in the treated area. If you experience any adverse effects, discontinue use and consult a healthcare professional.

Laser therapy is considered a very safe form of therapy with little to no side effects. Never discontinue use of medications prescribed by your doctor, but report improvements. Always consult with your doctor and follow the below considerations:

• Eyes: Never direct the laser into the eyes, as it can cause serious damage or injury.
• Pregnancy: Avoid using laser therapy on the abdominal or lower back area during pregnancy.
• Cancer: Do not use the device over known or suspected cancerous lesions or tumors.
• Active Infection: Avoid using the device on areas with active infections, as the therapy might exacerbate the condition.
• Thyroid Gland: Do not use the laser over the thyroid gland to avoid potential thyroid dysfunction.
• Photosensitive Skin Conditions: Individuals with photosensitive skin conditions or those taking medications that increase photosensitivity should avoid laser therapy.
• Epilepsy: Use caution in individuals with epilepsy, especially if the device emits pulsing light that could potentially trigger seizures.
• Bleeding Disorders: Avoid using the device on areas with recent or active bleeding, as laser therapy may affect blood clotting.

528 Innovations devices are registered with the FDA and have obtained 510(k) clearance. The FDA classifies lasers based on their safety, from Class 1 (Low power output: eye exposure safe) to Class 4 (Reserve caution: strict safety protocols due to risk of eye harm). 528 Innovations revolutionized the industry with a Class 3R laser, traditionally thought to be lower in power, and through our patent pending technology is delivering power levels previously only achievable with Class 4 lasers, but without the associated hazards. Our proprietary optical system allows for high total power output in a safe manner, making it ideal for both home use and medical practices. 

The FDA requires that manufacturers and distributors of medical devices in the United States register annually and submit a device list, a process known as “establishment registration.” 21 C.F.R. § 807 (2018); FDA, Device Advice: Comprehensive Regulatory Assistance: How to Study and Market Your Device: Device Registration and Listing, available at

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

The purpose of this registration requirement is to inform the FDA where medical devices are made, in the event of a public health emergency to which the agency must respond. 528 Innovations’ establishment registration can be found here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=328500