LimeLightRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816722022110), received between Apr 29, 2024 and Jul 2, 2024 — classified as 3 injuries.

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

• InjuryJul 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 12 JUNE 2024, CUTERA RECEIVED PHOTOGRAPHIC EVIDENCE OF A PARTIAL THICKNESS DERMAL BURN LOCATED ON THE PATIENT'S RIGHT LOWER ARM. THIS INJURY IS REPORTED TO HAVE OCCURRED SUBSEQUENT TO A LIMELIGHT PROCEDURE THAT WAS PERFORMED IN (B)(6) 2023. THE CLINIC HAS MULTIPLE LIMELIGHT HANDPIECES IN ITS INVENTORY AND IS CURRENTLY UNABLE TO PROVIDE THE SERIAL NUMBER OF THE HANDPIECE UTILIZED DURING THE PROCEDURE. THE CLINIC REPORTED THAT THE LIMELIGHT HANDPIECE WAS RETURNED TO CUTERA; HOWEVER, THERE IS NO RECORD OF A LIMELIGHT HANDPIECE BEING RETURNED TO CUTERA FROM THIS ACCOUNT AFTER DECEMBER 2023. AT THIS TIME, CUTERA IS AWAITING FURTHER DETAILS PERTAINING TO THE PATIENT, THE EXACT NATURE OF THE TREATMENT PERFORMED, AND THE RESOLUTION OF THE BURN INJURY. THIS INFORMATION IS PENDING AS CUTERA IS IN THE PROCESS OF OBTAINING THESE DETAILS FROM THE CLINIC.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19660718 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS IS A FOLLOW-UP TO THE INITIAL EMDR FILED ON 01-JUL-2024. AS REPORTED INITIALLY, THE LIMELIGHT PULSED LIGHT HANDPIECE WAS UTILIZED IN A MEDICAL PROCEDURE ON (B)(6) 2024 TO TREAT THE ANTERIOR ASPECTS OF BOTH THE UPPER AND LOWER LEGS, BILATERALLY. THE PRIMARY OBJECTIVE OF THIS INTERVENTION WAS THE MITIGATION OF BENIGN PIGMENTED LESIONS. POST PROCEDURE, THE PATIENT EXHIBITED SYMPTOMS OF SUPERFICIAL EPIDERMAL AND SUPERFICIAL PARTIAL THICKNESS BURNS. THE DERMAL INJURIES WERE TREATED WITH STEM CELL TREATMENT, IN CONJUNCTION WITH THE APPLICATION OF TOPICAL OINTMENTS EUCERIN AND AQUAPHOR. THE MEDICAL INSTITUTION HAS NOT RESPONDED TO CUTERA'S REQUESTS FOR SPECIFIC DETAILS PERTAINING TO THE PATIENT, THE TREATMENT PROTOCOL, AND THE SUBSEQUENT OUTCOME. SINCE THE INITIAL EMDR, THE DEVICE WAS EVALUATED BY A CUTERA FSE AND WAS FOUND TO BE WITHIN SPECIFICATION.

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

  MAUDE report 19652586 ↗
• InjuryApr 29, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INCIDENT REPORT: BURN FOLLOWING LIMELIGHT PROCEDURE SOURCE: CLINIC IN JAPAN. PATIENT INFORMATION: ADULT FEMALE. BURN DIMENSIONS: 3 CM X 1 CM. BURN CARE: INFORMATION NOT PROVIDED. BURN OUTCOME: BURN HEALED BY EPIDERMAL REGENERATION RESULTING IN A DEPRESSED SCAR (3 CM X 1 CM). AFFECTED AREA: FACE. PROCEDURE: LIMELIGHT. INDICATION FOR TREATMENT: NOT PROVIDED. PATIENT AGE: NOT SPECIFIED. PROCEDURE DATE: NOT SPECIFIED. THE CLINIC REPORTED AN ADVERSE EVENT IN WHICH THE PATIENT EXPERIENCED A BURN ON THE FACE AFTER UNDERGOING A LIMELIGHT PROCEDURE. FURTHER DETAILS REGARDING THE INDICATION FOR TREATMENT, PATIENT AGE, AND PROCEDURE DATE WERE NOT PROVIDED BY THE CLINIC. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE CLINICAL CASE. THE PATIENT UNDERWENT A SERIES OF 90 ENERGY PULSES DIRECTED AT THE FACIAL AREA. A BURN OCCURRED FOLLOWING A SINGLE PULSE, RESULTING IN A BURN SHAPED LIKE THE COOLING/TREATMENT WINDOW. THIS SUGGESTS THAT THE OPERATOR MOMENTARILY LOST CONTACT BETWEEN THE SKIN AND THE COOLING/TREATMENT WINDOW DURING ENERGY DELIVERY. SUCH LOSS OF CONTACT COMPROMISES EFFECTIVE COOLING OF THE UNDERLYING TISSUE DURING ENERGY ADMINISTRATION.

  Patient problems: Full thickness (Third Degree) Burn; Scar Tissue

  MAUDE report 19209963 ↗