Description of Event or Problem · 0
IPL HAIR REMOVAL DEVICE MODEL: CT05. SUBJECT: MISLEADING MEDICAL CLAIMS AND SEVERE SAFETY RISK ¿ IPL HAIR REMOVAL DEVICE CT05 (K251000) COMPLAINT TEXT: I AM WRITING TO URGENTLY REPORT A MEDICAL DEVICE SOLD ON AMAZON THAT HAS CAUSED ME CATASTROPHIC PERSONAL INJURY, IN ADDITION TO MAKING FALSE AND MISLEADING MEDICAL CLAIMS. AS A DIRECT RESULT OF USING THIS DEVICE, MY ENTIRE BODY SUFFERED SEVERE BURNS, AND I HAVE BEEN CLINICALLY DIAGNOSED WITH SECOND-DEGREE BURNS (PER U.S. CLINICAL BURN CLASSIFICATION STANDARDS) THAT ARE PERMANENT AND IRREVERSIBLE. THIS DEVASTATING INJURY STEMS DIRECTLY FROM THE DEVICE'S ACTUAL ENERGY OUTPUT DRASTICALLY EXCEEDING THE FDA-CLEARED PARAMETERS: WHILE THE FDA 510(K) CLEARANCE (K251000) EXPLICITLY SPECIFIES A MAXIMUM OUTPUT OF 13 J, THE PRODUCT MARKETED TO CONSUMERS CLAIMS A MAXIMUM ENERGY OUTPUT OF 19.8 J[INVALID]AND BASED ON THE SEVERITY OF MY INJURIES, THE ACTUAL OUTPUT MAY BE EVEN HIGHER THAN ADVERTISED. I URGENTLY REQUEST YOUR INVESTIGATION INTO THIS DANGEROUS PRODUCT, AS IT NOT ONLY MISLEADS CONSUMERS WITH UNAPPROVED MEDICAL CLAIMS BUT HAS ALREADY INFLICTED PERMANENT, LIFE-[INVALID]ING HARM. PRODUCT INFORMATION: PRODUCT: IPL HAIR REMOVAL DEVICE MODEL: CT05 AMAZON LISTING: HTTPS://WWW.AMAZON.COM/DP/B0DQ586Y2D , HTTPS://WWW.AMAZON.COM/DP/B0D179YR4G?TH=1 MANUFACTURER: UBROO / SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD FDA 510(K) CLEARANCE NUMBER: K251000 ACCORDING TO THE FDA 510(K) CLEARANCE (K251000), THIS DEVICE IS INDICATED FOR THE REMOVAL OF UNWANTED HAIR AND PERMANENT HAIR REDUCTION. HOWEVER, THE AMAZON LISTING MAKES CLAIMS THAT EXCEED THE CLEARED INDICATIONS, MISLEADING CONSUMERS[INVALID]INCLUDING MYSELF[INVALID]INTO BELIEVING THE PRODUCT IS SAFE FOR USE. MISLEADING MEDICAL CLAIMS THE PRODUCT LISTING REPEATEDLY CLAIMS: "PERMANENT HAIR REMOVAL" "HAIR FOLLICLES ENTER A DORMANT STATE PRODUCING PERMANENT RESULTS" "LONG-LASTING PERMANENT HAIR REMOVAL EFFECTS" FDA-CLEARED IPL DEVICES ARE INDICATED ONLY FOR PERMANENT HAIR REDUCTION, NOT PERMANENT HAIR REMOVAL[INVALID]A CRITICAL DISTINCTION THAT FALSELY IMPLIES THE PRODUCT IS MORE EFFECTIVE AND SAFER THAN IT ACTUALLY IS. UNSUBSTANTIATED CLINICAL CLAIMS THE LISTING CLAIMS: "UP TO 92.4% OF WOMEN REPORTED UP TO 96% HAIR REDUCTION AFTER 2 MONTHS." NO FDA-REVIEWED CLINICAL EVIDENCE IS PROVIDED TO SUPPORT THESE CLAIMS, WHICH FURTHER MISLEADINGLY INFLATE THE PRODUCT'S SAFETY AND EFFICACY. SEVERE SAFETY RISK ¿ OUTPUT ENERGY DISCREPANCY THE DEVICE IS ADVERTISED WITH A MAXIMUM ENERGY OUTPUT OF UP TO 19.8 J, WHILE THE FDA CLEARANCE DOCUMENTS EXPLICITLY SPECIFY AN OUTPUT ENERGY RANGE OF APPROXIMATELY 6¿13 J. MY PERSONAL INJURY CONFIRMS THAT THIS DISCREPANCY IS NOT MERELY A TECHNICAL ISSUE BUT A LIFE-THREATENING SAFETY HAZARD. IF THE MARKETED DEVICE EXCEEDS THE CLEARED ENERGY PARAMETERS, THIS INDICATES: THE DEVICE HAS BEEN MODIFIED BEYOND FDA CLEARANCE A SEVERE RISK OF BURNS, SKIN INJURY, PIGMENTATION ABNORMALITIES, AND PERMANENT DISABILITY THE DISTRIBUTION OF A DEVICE NOT SUBSTANTIALLY EQUIVALENT TO THE CLEARED VERSION[INVALID]VIOLATING FDA REGULATIONS CONSUMER SAFETY CONCERN EXCESSIVE LIGHT ENERGY EXPOSURE FROM HOME-USE IPL DEVICES POSES SEVERE RISKS, AS DEMONSTRATED BY MY EXPERIENCE: SEVERE BURNS (SECOND-DEGREE, PER U.S. CLINICAL CLASSIFICATION STANDARDS) BLISTERING PERMANENT SKIN DAMAGE IRREVERSIBLE DISABILITY CONSUMERS RELY ON FDA CLEARANCE TO MAKE SAFE PURCHASING DECISIONS, YET THIS PRODUCT'S MISLEADING CLAIMS AND NONCOMPLIANT ENERGY OUTPUT HAVE ALREADY CAUSED PERMANENT HARM. WITHOUT IMMEDIATE REGULATORY ACTION, MORE CONSUMERS WILL SUFFER PREVENTABLE, LIFE-[INVALID]ING INJURIES. REQUEST FOR INVESTIGATION AND ENFORCEMENT ACTION 1.VERIFYING WHETHER THE DEVICE'S MARKETING CONTAINS FALSE OR MISLEADING MEDICAL CLAIMS 2.CONFIRMING THE ACTUAL ENERGY OUTPUT OF THE MARKETED DEVICE AGAINST THE FDA-CLEARED PARAMETERS (6¿13 J) 3.ASSESSING THE FULL SCOPE OF SAFETY RISKS POSED BY THE NON-COMPLIANT DEVICE 4.ISSUING A RECALL OR REQUIRING AMAZON TO REMOVE THE PRODUCT TO PREVENT FURTHER HARM 5.HOLDING THE MANUFACTURER.