GentleYAG Pro-U 9914-00-9020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817495020044), received between Aug 16, 2017 and Aug 16, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjuryAug 16, 2017Insufficient Device Problem Information

  ON (B)(6) 2017 THE (B)(6) LASER AND MED SPA IN (B)(6) REPORTED THAT PATIENT WHO RECEIVED 2ND LASER HAIR REMOVAL TREATMENT HAD RESPONDED WITH BURNS AND BLISTERS ON TREATED AREA.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 6797694 ↗