ULIKE X

Additional Manufacturer Narrative

A CUSTOMER REPORTED INTERMITTENT UNINTENDED LIGHT EMISSION WAS OBSERVED DURING USE OF AN FDA-CLEARED CONSUMER IPL HAIR REMOVAL DEVICE (ULIKE). SPECIFICALLY, THE DEVICE INTERMITTENTLY EMITTED IPL FLASHES WHEN THE TREATMENT WINDOW WAS NOT IN CONTACT WITH SKIN, INCLUDING INSTANCES WHERE THE DEVICE WAS FULLY LIFTED IN THE AIR DURING REPOSITIONING. IN ADDITION, VISIBLE LIGHT LEAKAGE WAS OBSERVED FROM THE SIDE OF THE TREATMENT WINDOW DURING NORMAL FIRING. WE HAVE PROVIDED A VERIFICATION AND ANALYSIS REPORT FOR THE ISSUE OF SIDE LIGHT LEAKAGE. A PRELIMINARY ANALYSIS REPORT HAS BEEN PROVIDED FOR THE ISSUE OF NON-CONTACT AUTOMATIC LIGHTING, AND FURTHER ANALYSIS AND VERIFICATION WILL BE CONDUCTED UPON RECEIPT OF PHYSICAL DEFECT SAMPLES. THE RESULTS ARE DETAILED IN THE FILE ATTACHMENTS.

Description of Event or Problem

INTERMITTENT UNINTENDED LIGHT EMISSION WAS OBSERVED DURING USE OF AN FDA-CLEARED CONSUMER IPL HAIR REMOVAL DEVICE (ULIKE). SPECIFICALLY, THE DEVICE INTERMITTENTLY EMITTED IPL FLASHES WHEN THE TREATMENT WINDOW WAS NOT IN CONTACT WITH SKIN, INCLUDING INSTANCES WHERE THE DEVICE WAS FULLY LIFTED IN THE AIR DURING REPOSITIONING. THIS BEHAVIOR WAS REPRODUCIBLE ACROSS MULTIPLE SESSIONS AND OCCURRED DESPITE CORRECT USE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. IN ADDITION, VISIBLE LIGHT LEAKAGE WAS OBSERVED FROM THE SIDE OF THE TREATMENT WINDOW DURING NORMAL FIRING, SUGGESTING INCOMPLETE OPTICAL CONTAINMENT. THESE BEHAVIORS RAISE SAFETY CONCERNS, AS THE DEVICE IS EXPECTED TO PREVENT LIGHT EMISSION UNLESS PROPER SKIN CONTACT IS DETECTED AND TO FULLY CONTAIN EMITTED LIGHT WITHIN THE TREATMENT WINDOW. THE ISSUE WAS NOTICED EARLY IN OWNERSHIP AND PERSISTED INTERMITTENTLY THROUGHOUT USE. THE DEVICE WAS OPERATED UNDER NORMAL CONDITIONS USING THE ORIGINAL POWER ADAPTER CONNECTED DIRECTLY TO A STANDARD U.S. OUTLET, WITH NO CONVERTER PLUG. THE COOLING FAN OPERATED NORMALLY, AIRFLOW WAS PRESENT, AND THE SAPPHIRE TREATMENT WINDOW FELT COOL TO THE TOUCH. SKIN WAS CLEAN AND DRY DURING USE, THE DEVICE WAS ALLOWED TO COOL WHEN WARM, AND NO VISIBLE EXTERNAL DAMAGE WAS PRESENT. THE TRIGGER BUTTON FUNCTIONED NORMALLY. THE MANUFACTURER WAS CONTACTED AND PROVIDED WITH DETAILED DESCRIPTIONS OF THE ISSUE, RESPONSES TO TROUBLESHOOTING QUESTIONS, AND VIDEO DOCUMENTATION DEMONSTRATING LIGHT LEAKAGE. DESPITE THIS, THE MANUFACTURER DID NOT ACKNOWLEDGE THE BEHAVIOR AS A SAFETY DEFECT AND DID NOT PROVIDE A DEFINITIVE EXPLANATION OR CORRECTIVE ACTION ADDRESSING THE OFF-SKIN FIRING OR LIGHT LEAKAGE. THE RESPONSE FOCUSED ON ROUTINE TROUBLESHOOTING AND OFFERED A REPLACEMENT ONLY IF A DEFECT COULD BE CONFIRMED, WITHOUT ADDRESSING THE REPORTED SAFETY CONCERNS OR CONFIRMING WHETHER THE OBSERVED BEHAVIOR WAS WITHIN DESIGN SPECIFICATIONS. DUE TO THE UNRESOLVED SAFETY IMPLICATIONS AND LACK OF CORRECTIVE ACTION FROM THE MANUFACTURER, USE OF THE DEVICE WAS DISCONTINUED.