According to CEO David Michaels of Lexington International, manufacturer of the LaserComb, “CE certification is much like a passport for product sales to the 18 nations that make up the European Economic Area (EEA). With HairMax’s advanced treatment for thinning hair, it is important to show that the LaserComb meets the safety and health requirements established by the European Member States.”

The HairMax LaserComb is a unique laser light therapy device that is currently undergoing FDA review for clearance as a medical device for hair loss. The LaserComb has been certified in Canada as a Class 2 Medical Device cleared to stop hair loss and regrow scalp hair in men and women.

The CE marking refers to the safety of a product and CE certification is another major clearance by the LaserComb as being safe for use by consumers. The LaserComb also meets FDA requirements for laser safety. The CE marking indicates conformity with mandatory European safety requirements. European conformity is certified by following clear and understandable ‘conformity assessment procedures’. Lexington International is represented for regulatory affairs in Europe by Emergo Europe, headquartered in The Hague in the Netherlands.

“We often hear the question, ‘Is the LaserComb safe?’ said David Michaels. “We hope this goes a long way toward definitely answering that question.” The LaserComb was developed from nearly two decades of clinical research and is manufactured and patented in the USA with patents pending in over one hundred countries around the world.

- For more information on the Lasercomb, view our Lasercomb Information Page
- Looking to buy the Lasercomb online? Lasercomb Ordering Page

HLT