OtherOLP

THERAFACE PRO

Received Aug 28, 2023

Report MW5145021 · MDR key 17642081

Device

Generic name

Over-the-counter Powered Light Based Laser For Acne

Manufacturer

Therabody, Inc.

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

MULTIPLE CONSUMER COMPLAINTS OF THERAFACE PRO CLASS II MEDICAL DEVICE WITH THE COLD RING OVERHEATING CAUSING POTENTIAL FOR INJURY. MARKETING DIRECTLY FROM THE WEBSITE STATES "COLD RING HELPS REDUCE PUFFINESS UNDER EYES. DECREASES PAIN, INFLAMMATION, AND MUSCLE SPASMS" HOWEVER, IF THE COLD RING DOESN'T PRODUCE A COOLING EFFECT, BUT A HEATING EFFECT, THEN THE MARKETING LANGUAGE IS CLAIMING INCORRECT INFORMATION. THERABODY REFUSING REFUNDS AND REPLACEMENTS. BBB (BETTER BUSINESS BUREAU) RATING IS F. REFERENCE REPORT: MW5145020.