IPL DEVICE

Description of Event or Problem

I AM REPORTING CONCERNS ABOUT A BUSINESS IN (B)(6) CALLED "(B)(6). "THE OWNER INITIALLY CLAIMED TO HAVE THE NORDLY'S IPL SYSTEM, WHICH IS AN FDA-CLEARED, PROFESSIONAL-GRADE DEVICE USED BY LICENSED MEDICAL PROFESSIONALS. HOWEVER, WHEN I FURTHER QUESTIONED HIM, HE ADMITTED HIS DEVICE IS NOT A GENUINE NORDLY'S. INSTEAD, IT IS AN IPL/LASER MACHINE THAT HE SAYS WAS "ASSEMBLED WITH PARTS THAT HAVE THE SAME VOLTAGE AS A NORDLY'S." THIS RAISES SERIOUS CONCERNS THAT THE DEVICE IS NOT FDA-CLEARED, MAY NOT MEET SAFETY STANDARDS AND COULD CAUSE HARM TO CLIENTS. I HAVE ALSO READ REVIEWS FROM OTHER CLIENTS STATING THAT THEY SUFFERED SKIN BURNS AFTER TREATMENTS HERE, SUGGESTING UNSAFE USE OF EQUIPMENT. WHEN I RAISED MY CONCERNS, HE WAS VAGUE AND EVASIVE. HE GAVE ME INCONSISTENT INFORMATION ABOUT REFUNDS AND EVEN SUGGESTED I DISPUTE THE CHARGE WITH MY CREDIT CARD COMPANY INSTEAD OF ISSUING A PROPER REFUND. HIS LACK OF TRANSPARENCY ADDS TO MY CONCERN THAT THE EQUIPMENT MAY NOT BE LEGITIMATE OR SAFE. I BELIEVE THIS IS A SERIOUS PATIENT SAFETY ISSUE BECAUSE: ¿ THE DEVICE MAY NOT BE FDA-CLEARED. ¿ IT WAS ALLEGEDLY BUILT FROM PARTS, NOT A PROPERLY MANUFACTURED OR REGULATED SYSTEM. ¿ CLIENTS MAY BE AT RISK OF BURNS, INJURIES, OR LONG-TERM HARM. ¿ THE BUSINESS MISREPRESENTS THE DEVICE AS A GENUINE NORDLY'S IPL, WHICH IS MISLEADING TO CONSUMERS. PLEASE INVESTIGATE WHETHER THE IPL/LASER EQUIPMENT BEING USED AT (B)(6) MEETS FDA SAFETY AND CLEARANCE STANDARDS.