Diode 810nm Speed HP For Soprano Ice & XliRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 17290110120693), received between Nov 9, 2017 and Jan 25, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON PATIENT'S BACK OF LEGS (CALVES), ELBOWS, BUTTOCKS AND HIPS (OUTER) FOR HAIR REMOVAL. AS PER THE FACILITY, PATIENT WITH SKIN TYPE V/VI SUSTAINED BLISTERS AND BURNS ON ALL AREAS. THE FACILITY PROVIDED CARE FOR WOUNDS BY CLEANING AND HYDRATING. PATIENT WAS ALSO PROVIDED ALOE/AQUAPHOR. THESE INJURIES WERE DIAGNOSED AS 1ST AND PARTIAL 2ND DEGREE BURNS.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 8279869 ↗
• InjuryJun 25, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT WITH SKIN TYPE IV ON UPPER SHOULDER AND HAND FOR HAIR REMOVAL PROCEDURE. AS PER THE FACILITY NOTES, RN (REGISTERED NURSE) WENT OVER A TATTOO WITH HAIR REMOVAL HANDPIECE RESULTING IN BLISTERING ON PATIENT'S UPPER SHOULDER AND HAND. THE BLISTERING DID NOT SHOW UP RIGHT AWAY. IT WAS ALSO NOTED THAT THE FACILITY NURSE KNEW WHEN SHE DID THE TREATMENT THAT SHE SHOULD NOT HAVE GONE OVER THE TATTOO. HOWEVER, THE PATIENT WANTED HER TO PERFORM HAIR REMOVAL OVER TATTOO ANYWAY. PATIENT ALSO INFORMED THE NURSE THAT HE WAS GOING TO A WATER PARK THE NEXT DAY. BOTH FACILITY DOCTOR AND NURSE ADVISED AGAINST THE SUN EXPOSURE. PATIENT STATED THAT HE WOULD STAY IN THE SHADE AND COVER THE AREA. FACILITY GAVE THE PATIENT ANTIBIOTIC OINTMENT AND STERILE GAUZE AND INSTRUCTED PATIENT TO KEEP DRESSED. HE THEN RETURNED TO THE FACILITY ON (B)(6) 2018 AND LATER ON (B)(6) 2018. ON (B)(6) 2018, HE INFORMED THE DOCTOR THAT HE WAS GOING TO THE EMERGENCY ROOM TO HAVE THEM TAKE A LOOK AT IT. AT THAT TIME, THE FACILITY WAS NOT AWARE IF THE PATIENT WENT TO THE EMERGENCY ROOM. UPON PATIENT FOLLOW-UP BY ALMA ON 06/11/2018, FACILITY CONFIRMED THAT THE PATIENT DID NOT GO TO THE

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7634556 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUSPECTED DEVICE WAS USED ON SKIN TYPE III PATIENT FOR HAIR REMOVAL PROCEDURE ON HER LOWER FACE. THE PATIENT HAS RECEIVED TREATMENT BEFORE AS WELL WITH THE SAME SETTINGS. AS PER THE FACILITY, WHILE DOING THE PROCEDURE OPERATOR STARTED TO SMELL A BURNING SCENT AND CHECKED WITH THE PATIENT IF SHE WAS FINE. PATIENT RESPONDED THAT SHE WAS DOING FINE BUT SOON AFTER HANDPIECE ATTACHMENT (TAPERED TIP) ALLEGEDLY MELTED. IT DRIPPED ONTO PATIENT'S LEFT MIDDLE NECK AREA AND ALSO HER FINGER WHEN SHE TRIED BRUSHING OFF THE MELTED TIP FROM HER NECK. MEDICAL DIRECTOR AT THE FACILITY GAVE THE DIAGNOSIS OF PLASTIC BURNS. PATIENT WAS PROVIDED WITH IMMEDIATE COOLING ICE PACKS, ALOE VERA GEL, LED THERAPY AND MORE COLD COMPRESSES. SHE DECLINED ANY MEDICATION AND MEDICAL ATTENTION FROM THE FACILITY MEDICAL DIRECTOR. PATIENT STATED THAT SHE IS A DOCTOR AND WANTED TO TREAT HERSELF. AFTER LEAVING THE SPA, THE MEDICAL CARE DETAILS ARE UNKNOWN. ON (B)(6), FACILITY RECEIVED A LETTER FROM AN ATTORNEY INSTRUCTING THEM NOT TO CONTACT THEIR CLIENT (HEREBY, THE PATIENT IN THIS EVENT). ON (B)(6), ALMA LASERS PERFORMED PATIENT FOLLOW UP. BASED ON INFORMATION PROVIDED BY THE FACILITY, THE PATIENT HAS NOT RETURNED

  Patient problems: Burn(s)

  MAUDE report 7013905 ↗