LAMP, INFRARED, THERAPEUTIC HEATING
Received Mar 5, 2026 · Event occurred Jan 2, 2024
Report MW5184812 · MDR key 24521755
Device
Generic name
Lamp, Infrared, Therapeutic Heating
Manufacturer
UnknownPatient
65 YR · Female
- Insufficient Information
Narrative
Description of Event or Problem
A CHIROPRACTOR - (B)(6) - IN (B)(6) GAVE ME RIGHT LIGHT THERAPY FOR MY NEUROPATHY. UPON RESEARCH, THIS DEVICE IS NOT FDA CLEARED OR APPROVED FOR THE CLAIMS THAT SHE STATED. SHE STATED IT WOULD HELP ME REGROW MY BLOOD VESSELS AND FEEL BETTER. BASED ON PUBLICLY AVAILABLE FDA DATABASES, I HAVE NOT BEEN ABLE TO VERIFY FDA CLEARANCE FOR THIS DEVICE FOR THE STATED USES. ADDITIONALLY, THE PROMOTIONAL LANGUAGE APPEARS TO PROMISE DEFINITIVE RESULTS, WHICH RAISES CONCERNS ABOUT POTENTIAL MISREPRESENTATION TO PATIENTS. I AM CONCERNED THAT PATIENTS MAY NOT BE RECEIVING ACCURATE INFORMATION REGARDING: THE REGULATORY STATUS OF THE DEVICE, THE LEVEL OF CLINICAL EVIDENCE SUPPORTING THE CLAIMS POTENTIAL RISKS OR LIMITATIONS.