Because this is a Class IV laser with a very high energy output (10 Watts), it has a much higher potential danger threshold. As with the other Class IV devices, clinical evidence supporting the use of such high power is lacking.
According to their 510K letter with the FDA: Companion Laser/LiteCure is a heating lamp.
What is a Class IV Laser?
FDA - Description of Class IV Laser (Laser Product Hazard): Immediate skin hazard and eye hazard from exposure to either the direct or reflected beam; may also present a FIRE HAZARD
Wikepedia: Class IV/4 lasers CAN BURN SKIN, and in some cases, even scattered light can cause eye and/or skin damage.
Europe (EN & IEC): Class IV is the highest class of laser radiation. Radiation in this class is very dangerous, and viewing of the diffuse reflection may be dangerous. Class 4 laser beams are CAPABLE OF SETTING FIRE to materials onto which they are projected.
The Microlight ML830® Cold Laser is a Class IIIB NHN (non thermal) Laser. It has been safely used around the world for over 20 years.
Companion Laser®, Litecure®, Pegasus Laser® is a registered trademark and is not affiliated in any way with the owner or any content of this web site. ML830® is a registered trademark and is not affiliated in any way with the owner or any content of this web site.