5i Series Laser Therapy System (IR 975nm Module Combined Red 638nm Laser System) - [Backorded through May 28th]

Yes, the system was intentionally engineered for safety, meeting the FDA Class 3R safety classification, which makes it suitable for both clinical and supervised home use. By combining proprietary optical engineering and controlled energy delivery, 528 Innovations delivers clinical-grade therapeutic performance within this framework. A key benefit of the Class 3R rating is that no safety eyewear is required for operation, unlike Class 3B or Class 4 devices. However, because the 5i Series delivers power levels typically reserved for clinical settings, it remains a powerful therapeutic device. Users must always handle the device carefully and never shine the laser directly into the eye, or knowingly direct it outwardly at someone or something.

The 528i Laser Therapy System incorporates FDA-cleared laser modules designed to emit energy in the visible and near-infrared spectrum. The device is intended for use only as authorized through applicable FDA 510(k) clearances, and cleared indications for use may vary based on system configuration, laser parameters, and recommended treatment protocols. 528 Innovations does not promote, recommend, or authorize use of its products outside of their FDA-cleared indications. As the manufacturer, 528 Innovations does not provide medical advice, prescribe treatment, or promote the use of the device for specific medical conditions beyond its FDA-cleared indications. Any clinical recommendations, treatment decisions, or therapeutic applications involving the 528i Laser Therapy System are made solely by the treating licensed physician or wellness practitioner. Such decisions are based on the practitioner's independent clinical training, experience, and professional judgment, and are made in accordance with applicable medical standards and laws governing their scope of practice. These decisions are entirely independent of the manufacturer, 528 Innovations.

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.

The 528i Laser Therapy System includes FDA-cleared devices with specific indications for use as authorized through applicable FDA 510(k) clearances. Cleared indications and parameters may vary by device configuration, wavelength, and treatment protocol. To ensure consistent and optimal application, the 528i Mobile App provides a library of expert-curated programs and presets, which guide users through the appropriate therapeutic timing, ranging from a few minutes to an hour. These programs are structured around the device’s cleared indications for use and are designed to minimize user error by providing step-by-step guidance on dosing and application.

DISCLAIMER: 528 Innovations does not promote, recommend, or authorize use of its products outside their FDA-cleared indications for use. Information provided by 528 Innovations is for educational and informational purposes only and is not intended to constitute medical advice, diagnosis, or treatment recommendations. All healthcare decisions should be made in consultation with an appropriately licensed provider. Individuals with specific medical conditions or health concerns should consult their licensed healthcare provider to determine whether laser therapy is appropriate for their individual needs.

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.
• Individuals with a history of active seizure disorders should only use this device under the guidance and direction of a qualified healthcare provider, particularly when applying it to the head.

The 528i Laser Therapy System includes FDA-cleared laser modules that emit energy in the visible and near-infrared spectrum and are intended for use only as authorized through applicable FDA 510(k) clearances. Modules available for purchase 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