inforMED
InjuryPAY

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

Unknown

Patient

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.