Description of Event or Problem · 0
SUBJECT: FORMAL COMPLAINT ¿ INNZA HOME IPL HAIR REMOVAL DEVICE CONTENT: I AM REPORTING THE INNZA HOME IPL HAIR REMOVAL DEVICE FOR SERIOUS REGULATORY VIOLATIONS, FALSE ADVERTISING, AND SAFETY CONCERNS. THE DEVICE IS SOLD ON AMAZON AND OTHER PLATFORMS. KEY ISSUES INCLUDE: UNREGISTERED CLASS II MEDICAL DEVICE: MARKETED AS AN "IPL HAIR REMOVAL DEVICE," WHICH IS CLASSIFIED AS A CLASS II MEDICAL DEVICE BY FDA. NO 510(K) PREMARKET NOTIFICATION EXISTS FOR THIS PRODUCT, AND THE MANUFACTURER IS NOT REGISTERED WITH THE FDA. MISBRANDING & LABELING VIOLATIONS: DEVICE, PACKAGING, AND USER MANUAL LACK MANUFACTURER INFORMATION, VIOLATING 21 CFR 801.1(A). INSTRUCTIONS FOR USE ARE INCOMPLETE: NO CONTRAINDICATIONS LISTED (E.G., FOR DARKER SKIN TONES), VIOLATING 21 CFR 801.109(C). NO ELECTROMAGNETIC COMPATIBILITY COMPLIANCE INFORMATION (IEC 60601-1-2) IS PROVIDED. CONTRADICTORY TECHNOLOGY CLAIMS & RADIATION SAFETY VIOLATIONS: PACKAGING CLAIMS, "IPL TECHNOLOGY," BUT THE MANUAL CLAIMS "LASER HAIR REMOVAL," CREATING MATERIAL MISREPRESENTATION. IF MARKETED AS A LASER, THE DEVICE LACKS 510(K) CLEARANCE, LASER CLASS DESIGNATION, AND REQUIRED RADIATION SAFETY WARNINGS PER 21 CFR 1040.10. THERAPEUTIC CLAIMS SUCH AS "PAINLESS TREATMENT," "KEEPS SKIN BELOW 5°C," AND "75¿96% HAIR REDUCTION" ARE UNSUBSTANTIATED AND EXCEED WHAT IS PERMITTED FOR AN OVER-THE-COUNTER CONSUMER PRODUCT. INJURY CAUSED BY THE DEVICE: DURING NORMAL USE OF THIS DEVICE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS, I SUSTAINED SEVERE BURNS ON MY LEGS. I AM ABLE TO PROVIDE PHOTOGRAPHS OF THE INJURIES AND MEDICAL REPORTS AS EVIDENCE. MANUFACTURER & SELLER INFORMATION: MANUFACTURER: ZHONGSHANWENJINGSHANGMAOYOUXIANGONGSI. BUSINESS ADDRESS: 1 1 2 4 6 0, 5 2 8 4 0 0, C N P H O N E : + 1 ( 3 0 2 ) 6 5 8 - 7 4 1 2. AMAZON SELLER: INNZA REQUEST FOR ACTION: INVESTIGATE INNZA FOR FALSE ADVERTISING, MISBRANDING, AND SAFETY VIOLATIONS. ENFORCE 510(K) CLEARANCE AND FDA ESTABLISHMENT REGISTRATION BEFORE ALLOWING SALES. REMOVE THE PRODUCT FROM THE MARKET UNTIL COMPLIANCE IS CONFIRMED.