MAUDE Adverse Event Report: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD. NEURONIC LIGHT; LAMP, INFRARED, THERAPEUTIC HEATING

Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) | my mother was tricked into buying their device for alzheimer's because of her slick marketing.It burned her scalp because it was a private-labeled device from china.Additional product details: the website claims fda-listed (https://www.Neuronic.Online/) but it's not registered in the fda database (https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfrl/textsearch.Cfm) this company makes claims for devastating medical diseases they have no research or proof for right on their front page.They are stealing research unrelated to them while private labeling a device from china (https://www.Neuronic.Online/research/alzheimers-disease-and-light-therapy-research-neuron ic).

• Brand Name: NEURONIC LIGHT
• Common Device Name: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD.
• MDR Report Key: 25461182
• Report Number: MW5189209
• Device Sequence Number: 15294475
• Product Code: ILY
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Unknown