PLATINUMLED THERAPY LIGHTS: BIOMAX 900

Description of Event or Problem

I PURCHASED A BIOMAX 900 RED LIGHT THERAPY DEVICE FROM PLATINUM LED THERAPY AT PLATINUMTHERAPYLIGHTS.COM, WHICH ON THEIR SITE IS ADVERTISED AS AN FDA-APPROVED CLASS 2 MEDICAL DEVICE. I REVIEWED THE INSTRUCTIONS CAREFULLY PRIOR TO USING THE DEVICE, AND FOLLOWED THE COMPANY'S INSTRUCTIONS REGARDING HOW FAR AWAY TO STAND AND HOW LONG TO USE THE DEVICE (ACTUALLY, I USED IT FOR EVEN LESS TIME THAN WAS SUGGESTED). THE THIRD TIME I USED THE DEVICE (OVER THE COURSE OF TWO WEEKS) IT CAUSED THE SKIN ON MY FACE TO BLISTER. I AM VERY CONCERNED THAT USING THE DEVICE EVEN MORE CONSERVATIVELY THAN THE COMPANY SUGGESTED CAUSED SKIN DAMAGE WHEN RED LIGHT IS SUPPOSED TO SAFE AND HEALTHY. I NOTIFIED THE COMPANY OF THIS SIDE EFFECT, AND THEY TOLD ME THEIR LIGHT IS SAFE WHEN USED CORRECTLY. THEY THEN TOLD ME TO STAND MUCH FURTHER AWAY FROM THE LIGHT. I POINTED OUT THIS DID NOT ALIGN WITH THEIR INSTRUCTIONS FOR USE AND ASKED WHY THEY MADE SUCH A POWERFUL LIGHT (AND ADVERTISE IT AS BEING "BETTER" THAN LIGHTS WITH LESS POWER) IF IT'S IN FACT DANGEROUS TO USE AS DIRECTED, BUT GOT NO RESPONSE. I TOOK A PHOTO OF ONE OF THE BLISTERS UNDER MY EYE THAT THIS CAUSED AND AM HAPPY TO SUBMIT IT IF NEEDED. FDA SAFETY REPORT ID # (B)(4).