Notice: Risk of thermal harm from therapeutic medical lasers, intense pulsed light and light emitting diodes

February 8, 2016
Our file number: 16-101141-793

Scope:

Light-based medical devices for cosmetic or therapeutic indications intended for sale in Canada. Light-based devices covered by this notice may include devices with laser, intense pulsed light (IPL), or light emitting diode (LED) energy sources. This notice does not apply to surgical lasers intended primarily for excision, incision, vaporization, ablation, hemostasis, or photocoagulation of soft tissue.

Context:

This notice is to communicate Health Canada's position regarding the scientific evidence required to demonstrate an acceptable risk-benefit ratio for light emitting medical devices indicated primarily for cosmetic and/or therapeutic treatments where the light source is key to the claimed mechanism of action.

Manufacturers will need to include data which clearly demonstrates that all hazards related to potential thermal damage to the skin have been removed or sufficiently mitigated by product design.

The risk-benefit analyses should demonstrate that all patient risks have been thoroughly assessed and that all reasonable mitigations have been implemented.

These devices are frequently used in non-medical clinics or beauty salons, therefore; the end user applying treatment may have limited training or knowledge of the risks associated with laser, IPL or LED treatments. For this reason, labeling mitigations alone (for example, requiring constant applicator motion, warning of potential burns, or recommending use only by "trained professionals") are unlikely to be considered by Health Canada to be adequate mitigation for products with identified thermal injury risks.

Effective immediately, class III and IV medical device licence applications for these types of devices need to include detailed skin temperature testing quantifying induced temperature over time. This testing must be performed under the system's worst case exposure conditions (for example, maximum power output, minimum spot size, skin contact with the applicator, no applicator motion, etc.). Testing should be representative of all Fitzpatrick skin types that the system is indicated to treat. Manufacturers of Class II medical devices should also ensure similar testing has been conducted and is available on request.

A maximum skin temperature in excess of 45°C will be deemed unsafe unless an objective and scientifically sound rationale is provided. Maximum skin temperatures above 45°C without an acceptable rationale may be grounds for the refusal of the licence application or amendment.

Manufacturers will need to demonstrate in their application that the benefits of their device outweigh all patient risks. Please note that, as safety and effectiveness requirements continue to evolve, a comparison to existing, licensed devices alone will not be sufficient to support a new system's thermal safety; device-specific testing will be required.

Please direct any questions or comments regarding the content of this Notice to the following:

Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Foods Branch
Health Canada
2934 Baseline Road, Tower B
Address Locator: 3403A
Ottawa, Ontario
K1A 0K9

Email: mdb_enquiries@canada.ca
Telephone: 613-957-7285
Fax Number: 613-957-6345

References:

  • Moritz, A. Re, and F. C. Henriques Jr. "Studies of Thermal Injury: II. The Relative Importance of Time and Surface Temperature in the Causation of Cutaneous Burns*." The American journal of pathology 23.5 (1947): 695.
  • IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1
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