LightSheer Infinity UHP 805Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290109140438), received between May 21, 2019 and Oct 11, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN AREA FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER INFINITY LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY. THEY MENTIONED THEY NEEDED TO CALIBRATE THE SYSTEM A FEW TIMES DURING PROCEDURE. ON (B)(6) A PATIENT REPORTED ON MARKS AND HYPERPIGMENTATION AND UNCOMFORTABLE IN THE TREATED AREA. NO REPORTS OF BROKEN SKIN, BLEEDING, BLISTERS, AND NO REPORTED ERROR CODES AT THE TIME OF THE CALL.

  Patient problems: Burn(s)

  MAUDE report 9179704 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN BODY PART FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER INFINITY LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 8914531 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN/SKIN REACTION OF UNKNOWN SEVERITY TO AN UNKNOWN BODY PART FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER INFINITY LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 8782760 ↗
• InjuryMay 21, 2019Device Handling Problem; Device Handling Problem

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED HYPO-PIGMENTATION TO THE LEGS FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER INFINITY LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 8629353 ↗