AMIRO S1 FACIAL RF SKIN TIGHTENING DEVICE
Received Oct 16, 2023 · Event occurred Sep 24, 2023
Report MW5147044 · MDR key 17949790
Device
Generic name
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
Manufacturer
UnknownPatient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
I BOUGHT AN $699 RF(RADIO FREQUENCY) DEVICE ONLINE. (HTTPS://AMIROBEAUTY.COM/PRODUCTS/AMIROS1-GOLDEN-DOT-MATRIX-RF-SKIN-TIGHTENINGMACHINE?GCLID=CJ0KCQJW7JOPBHCFARISAL3BOBE1OOVOAJWGUNJX3NQL4PIYEK9ZUDTZFHCIWFFCG2PGPODWMXQRLNMAAS4MEALW_WCB), AND THEN I NOTICED A LOT OF ARTICLES DISCUSSING THE SAFETY CONCERNS OF THIS DEVICE. SOME PEOPLE SAID THEIR SKIN WAS HURT BY THE DEVICE. THEN I FOUND OUT IT IS NOT FDA CLEARED, ACCORDING TO THE RULES, A RF DEVICE MUST BE FDA CLEARED TO MARKET AND SALE IN THE STATES. I CONTACTED THE MERCHANT, THEY DON'T KNOW ABOUT THIS RULE AT ALL. THEY STATED THEY ARE CE CLEARED, AND BECAUSE THEY DON'T HAVE INTERNATIONAL WAREHOUSE, THEY CAN'T PERFORM RETURNS FOR ME. THIS IS JUST RIDICULOUS.