Description of Event or Problem · 0
AS AN AVID CONSUMER OF AT-HOME HAIR REMOVAL DEVICES AND A SKINCARE TECHNOLOGY ENTHUSIAST, I WRITE TO REPORT CRITICAL REGULATORY VIOLATIONS BY MILEY TECHNOLOGY (HEBEI) CO., LTD. REGARDING ITS "IOUNIYA LASER HAIR REMOVAL DEVICE" (LINK?HTTPS://WWW.AMAZON.COM/LASER-HAIR-REMOVAL-DEVICE-MLY-T069/DP/B0D53DHZJ6?REF_=AST_STO_DP&TH=1?MODEL?MLY-T069?ASIN ON AMAZON: B0D53DHZJ6). MY INVESTIGATION REVEALS UNLAWFUL MARKETING OF AN UNREGISTERED MEDICAL DEVICE AND DECEPTIVE ADVERTISING, DETAILED BELOW WITH LEGAL CITATIONS: AS A VERIFIED PURCHASER OF THE "IOUNIYA LASER HAIR REMOVAL DEVICE VIA AMAZON LINK: HTTPS://WWW.AMAZON.COM/LASER-HAIR-REMOVAL-DEVICE-MLYT069/DP/B0D53DHZJ6?REF_=AST_STO_DP&TH=1) AND A SKINCARE TECHNOLOGY ENTHUSIAST, I WRITE TO REPORT CRITICAL REGULATORY VIOLATIONS BY MILEY TECHNOLOGY (HEBEI) CO., LTD. REGARDING THE PRODUCT (MODEL: MLY-T069, ASIN: B0D53DHZJ6). MY INVESTIGATION REVEALS UNLAWFUL MARKETING OF AN UNREGISTERED MEDICAL DEVICE AND DECEPTIVE ADVERTISING, DETAILED BELOW WITH LEGAL CITATIONS: 1. UNREGISTERED CLASS II MEDICAL DEVICE (510(K) VIOLATION) THE PRODUCT IS MARKETED AS AN "IPL (INTENSE PULSED LIGHT) DEVICE," A CLASS II MEDICAL DEVICE UNDER FDA CLASSIFICATION. HOWEVER, NO 510(K) PREMARKET NOTIFICATION IS FOUND IN FDA'S DATABASE FOR THIS MODEL OR PRODUCT. - LEGAL BASIS: FD&C ACT § 510(K) MANDATES MANUFACTURERS TO SUBMIT A 90-DAY PREMARKET NOTIFICATION BEFORE DISTRIBUTING CLASS II DEVICES. 2. INADEQUATE LABELING & MISBRANDING (A) MISSING DEVICE MARKINGS THE PRODUCT LACKS ESSENTIAL LABELS ON ITS BODY, VIOLATING: - 21 CFR 801.1(A): REQUIRES CONSPICUOUS DISPLAY OF THE MANUFACTURER'S NAME, ADDRESS, AND BUSINESS INFORMATION. - IEC 60601-1 7.2.2: ME EQUIPMENT SHALL BE MARKED WITH: ? THE NAME OR TRADEMARK AND CONTACT INFORMATION OF THE MANUFACTURER; (II) A MODEL OR TYPE REFERENCE; (II) A SERIAL NUMBER OR LOT OR BATCH IDENTIFIER; AND (IV) THE DATE OF MANUFACTURE OR USE BY DATE, IF APPLICABLE. ¿ THE NAME OR TRADEMARK OF THE MANUFACTURER; AND ¿ A MODEL OR TYPE REFERENCE. (B) UNMARKED STORAGE CONDITIONS THE PACKAGING OMITS REQUIRED ENVIRONMENTAL MARKERS FOR TRANSPORT/STORAGE, CONTRADICTING: - IEC 60601-1 7.2.17*: PROTECTIVE PACKAGING IF SPECIAL HANDLING MEASURES HAVE TO BE TAKEN DURING TRANSPORT OR STORAGE, THE PACKAGING SHALL BE MARKED ACCORDINGLY (SEE ISO 780). THE PERMISSIBLE ENVIRONMENTAL CONDITIONS FOR TRANSPORT AND STORAGE SHALL BE MARKED ON THE OUTSIDE OF THE PACKAGING (SEE 7.9.3.1 AND ISO 15223-1). 3. UNAPPROVED MEDICAL CLAIMS, "PAINLESS TREATMENT", THAT EXCEED THE SCOPE OF CONSUMER ELECTRONICS - MEDICAL DEVICE CLASSIFICATION TRIGGER? THE CLAIM "PERMANENT AND COMPLETELY PAINLESS" TARGETS CLINICAL TREATMENT, CLASSIFYING THE DEVICE AS A CLASS II MEDICAL DEVICE UNDER THE FD&C ACT. SUCH CLAIMS MAY ONLY BE MADE AFTER OBTAINING 510(K) PREMARKET CLEARANCE, WHICH IOUNIYA HAS NOT ACHIEVED. - SMOOTH SKIN CLAIMS IN LISTING: "LASTING SMOOTH SKIN CAN BE ACHIEVED AFTER 8 WEEKS" CONSTITUTES MEDICAL DEVICE CLAIMS THAT MAY ONLY BE MADE AFTER OBTAINING 510(K) CLEARANCE AS A CLASS II DEVICE UNDER 21 CFR 807.20(A) AND 21 CFR 801.1. 4. MISLEADING PROMOTION - INCONSISTENT INPUT PARAMETERS ON ADAPTER LABELING THE ADAPTER'S NAMEPLATE IS MARKED "1A INPUT," WHILE THE PACKAGING CARTON STATES "1.5A MAX." THIS DISCREPANCY CREATES MATERIAL MISLEADING REGARDING POWER CONSUMPTION, RISKING USER MISCONNECTION AND POTENTIAL ELECTRICAL HAZARDS (E.G., OVERHEATING OR FIRE). - OUTDATED WEEE DIRECTIVE IN USER MANUAL THE INSTRUCTION MANUAL REFERENCES THE REPEALED WEEE DIRECTIVE 2002/96/EC, WHEREAS THE CURRENT VALID STANDARD IS 2012/19/EU. THIS MISREPRESENTATION MISLEADINGLY IMPLIES COMPLIANCE WITH OBSOLETE RECYCLING REGULATIONS, VIOLATING CONSUMER TRUST IN PRODUCT CERTIFICATION. REQUEST FOR ENFORCEMENT - ISSUE A WARNING LETTER UNDER FD&C ACT § 302 FOR 510(K) NON-COMPLIANCE. - ORDER A PRODUCT RECALL AND CONSUMER REFUNDS. - REQUIRE LABELING UPDATES TO MEET 21 CFR 801 AND *IEC 60601-1*. - PUBLICLY NOTIFY CONSUMERS VIA FDA'S MEDWATCH. MANUFACTURER INFORMATION - NAME: MILEY TECHNOLOGY (HEBEI) CO., LTD. - ADDRESS: BUILDING 3, HIGH-TECH INDUSTRIAL ZONE, SOUTH XINNENG STREET, GUANTAO ECONOMIC DEVELOPMENT ZONE, HANDAN, HEBEI, CHINA.