Health Canada has announced that effective immediately evidence will be required to demonstrate that all hazards associated with thermal damage to the skin are eliminated or appropriately mitigated for light emitting medical devices. Affected devices include devices with laser, intense pulsed light (IPL), or light emitting diode (LED) energy sources.
The new evidence requirements impact class III and IV medical device license applications. Although manufacturers of class II medical devices are not required to submit the necessary evidence similar supportive data should be on file and available upon request.
The affected devices must undergo skin temperature testing quantifying induced temperature over time. A maximum skin temperature in excess of 45°C will be deemed unsafe and the application may be refused unless a scientific rationale is provided.