Smooth Beauty Laser SRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B5863426), received between Dec 29, 2017 and Dec 29, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2017Device Operates Differently Than Expected

  THE CUSTOMER ((B)(6)) RETURNED AN AGE-DEFYING LASER (ADL) DEVICE BACK TO (B)(6) WHILE CLAIMING HER HUSBAND, (B)(6) USED THE DEVICE ALL OVER HIS FACE AND FOREHEAD FOR THE FIRST TIME THE DAY ((B)(6) 2017) BEFORE THE STROKE, AND THAT THEY BELIEVED IT WAS ASSOCIATED WITH THE USE OF THE ADL. THE CUSTOMER WAS RELUCTANT TO PROVIDE ANY FURTHER INFORMATION ABOUT HER HUSBAND'S CONDITIONS AND CONFIRMING "NO NEED TO FOLLOW-UP". ULTIMATELY SHE WANTED TO OBTAIN A REFUND FOR THE DEVICE, WHICH WAS OUT OF WARRANTY AND REFUND PERIOD. (B)(6) OBLIGED AND PROVIDED THE REFUND, WHILE CONFIRMING THE DEVICE WAS FUNCTIONING PROPERLY WITHOUT ANY DEFECT.

  Patient problems: Stroke/CVA

  MAUDE report 7156086 ↗