Description of Event or Problem · 0
I AM WRITING TO FILE A FORMAL COMPLAINT REGARDING SERIOUS REGULATORY VIOLATIONS BY MEDICUBE CONCERNING THEIR "RF ULTRA TUNE 40.68" DEVICE, CURRENTLY SOLD ON AMAZON (ASIN: (B)(4)) AND THE COMPANY'S DIRECT-TO-CONSUMER WEBSITE (MEDICUBE.US). THIS COMPLAINT INVOLVES THE ILLEGAL MARKETING OF AN UNREGISTERED CLASS II MEDICAL DEVICE AND SAFETY INCIDENTS. 1. ILLEGAL MARKETING OF UNREGISTERED CLASS II MEDICAL DEVICE. THE MEDICUBE RF ULTRA TUNE 40.68 UTILIZES RADIOFREQUENCY (RF) AND MICROCURRENT (MC) TECHNOLOGIES FOR FACIAL TREATMENT. ITS ADVERTISED BENEFITS INCLUDE BOOSTING SKIN'S RADIANCE AND ELASTICITY, ADDING VOLUME TO FACIAL CONTOURS, AND LINE CARE. ACCORDING TO FDA CLASSIFICATION GUIDELINES, THIS DEVICE FALLS UNDER CLASS II MEDICAL DEVICES REQUIRING 510(K) PREMARKET CLEARANCE. HOWEVER, THE PRODUCT IS CURRENTLY ONLY REGISTERED AND LISTED AS A CLASS I MEDICAL DEVICE UNDER THE CATEGORY OF "MASSAGER". VIOLATIONS: - NO 510(K) PREMARKET NOTIFICATION FOUND IN FDA DATABASE - DEVICE MARKETED WITH MEDICAL CLAIMS WITHOUT PROPER CLEARANCE LEGAL BASIS: 21 USC § 360(K) (FD&C ACT § 510(K)); 21 CFR 807.81 2. SAFETY INCIDENT REPORT FOLLOWING MANUFACTURER INSTRUCTIONS, I SUSTAINED SEVERE BURNS CHARACTERIZED BY CIRCULAR PATTERNS MATCHING THE DEVICE'S METAL PROBE CONFIGURATION. THE INJURY REQUIRED MEDICAL TREATMENT AND RESULTED IN SIGNIFICANT RECOVERY TIME AND EXPENSE. THIS INCIDENT, COMBINED WITH THE DEVICE'S UNREGISTERED STATUS, RAISES SERIOUS SAFETY CONCERNS ABOUT QUALITY CONTROL AND REGULATORY COMPLIANCE. 3. REQUEST FOR ACTION - IMMEDIATE MARKET REMOVAL: ISSUE CEASE AND DESIST ORDERS TO REMOVE THE DEVICE FROM ALL US MARKETS PENDING PROPER 510(K) CLEARANCE - WARNING LETTERS: ISSUE FDA WARNING LETTERS CITING VIOLATIONS OF 21 USC § 360(K), 21 CFR 807.81, AND APPLICABLE LABELING REQUIREMENTS - PUBLIC SAFETY ALERT: CONSIDER ISSUING A PUBLIC NOTIFICATION THROUGH FDA'S SAFETY COMMUNICATION OR MEDWATCH SYSTEM - IMPORT ALERT: PLACE THE DEVICE AND RELATED PRODUCTS UNDER IMPORT SURVEILLANCE THIS CASE PRESENTS CLEAR VIOLATIONS OF FEDERAL MEDICAL DEVICE REGULATIONS AND POSES ONGOING PUBLIC HEALTH RISKS. I RESPECTFULLY REQUEST IMMEDIATE INVESTIGATION AND ENFORCEMENT ACTION TO PROTECT AMERICAN CONSUMERS.