The Standards Behind LightStim

LightStim devices are FDA-cleared, which is the correct term for Class II medical devices like ours. The FDA clears a device through the 510(k) process after reviewing evidence that it's as safe and effective as a legally marketed device with the same intended use. "FDA-approved" refers to a different process, premarket approval, which applies mainly to Class III devices.

ISO 13485 is the international standard for medical-device quality management systems. It covers how devices are designed, built, tested and tracked, including supplier controls, complaint handling and corrective actions. Our quality system is certified by an independent certification body, which sends auditors to review it every year.

The Medical Device Single Audit Program lets one audit of a manufacturer's quality system cover the requirements of several regulators: the U.S., Canada, Brazil, Australia and Japan. Health Canada requires an MDSAP certificate for Class II and higher medical device licences.

LightStim devices are designed, engineered and manufactured at our facility in Irvine, California. Some components, like LEDs and electronic parts, come from qualified suppliers that our quality system approves and monitors.

Each LightStim device is tested to recognized medical-device safety standards before release, and its instructions for use explain how to use it safely. Read them before your first treatment, and contact our team with any questions.

Contact our customer care team through our contact page. Every report is reviewed through our complaint-handling process, and we notify the FDA when required.