YONKER PHOTOTHERAPY

Description of Event or Problem

THE UNIT IS A UVB LAMP USED TO TREAT PSORIASIS OR VITILIGO. CLASS II MEDICAL DEVICE THAT REQUIRES PRESCRIPTION TO PURCHASE. THE INSTRUCTIONS STATE THAT IF YOU RECEIVE A MILD BURN OR ITCH ON THE SKIN, INCREASE THE TREATMENT TIME. THIS IS A HUGE ERROR AND WILL LEAD TO SERIOUS BURNS IF PURCHASED BY PEOPLE WHO DO NOT UNDERSTAND PHOTOTHERAPY. OTHER ERRORS: UNIT IS NOT 510K CLEARED AS REQUIRED. I ASKED THE COMPANY ABOUT THIS BUT THEY SAID THEY DO NOT HAVE 510K. A PRESCRIPTION IS REQUIRED TO PURCHASE. I WAS NOT ASKED TO SUBMIT A PRESCRIPTION. ANYBODY CAN BUY THIS THROUGH (B)(6). THE PRODUCT COMES FROM (B)(4) BUT THERE IS NO MENTION OF THAT FACT. LABELING DOES NOT INCLUDE INSTRUCTIONS AS TO HOW TO PROGRAM THE TIMER. THERE IS NO MENTION OF WHO THE MANUFACTURER WAS OR CONTACT INFORMATION. THERE IS NO UDI LABEL ON THE BOX OR THE DEVICE. THERE ARE NO WARNINGS, CAUTIONS OR PRECAUTIONS ON BOX. THERE IS NOTHING ON THE BOX THAT REQUIRES A DOCTOR'S PRESCRIPTION. VERY CLEAR THAT A USABILITY STUDY WAS NOT PERFORMED. THERE ARE NO STATEMENTS ON THE BOX WARNING OF UV RADIATION. TRANSLATION IS PROFANITY. VERY DIFFICULT TO FIGURE OUT WHAT INSTRUCTIONS ARE TRYING TO TELL YOU. UNIT DOES NOT WORK. THEY SENT 220 UNIT POWER SUPPLY. THEY HAVE NOT RESPONDED TO MY REQUEST FOR SUPPORT. RADIATION INTENSITY CHART HAS VALUES EXPRESSED IN MW/CM KM2. WHAT IS THAT? THERE IS A LOT WRONG WITH THIS DEVICE BUT IT WILL CAUSE SERIOUS BURNS IF YOU FOLLOW THE INSTRUCTIONS AS STATED IN THE MANUAL. FDA SAFETY REPORT ID #: (B)(4).