MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY); POWERED LASER SURGICAL INSTRUMENT

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Hypopigmentation (4838)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation determined that the reported injury is transient; however, long-term pigmentary changes may occur in the affected area.The reported skin reaction is consistent with known and anticipated adverse reactions associated with energy-based treatments, as described in the device labeling.Historical data, including a review of device history records (dhrs) and service call records, revealed no relevant abnormalities or similar events associated with the device.The device was requested for inspection; however, it was not returned by the customer, and multiple follow-up attempts did not receive a response.Based on the available information, the event is most likely attributable to user error.This report is submitted in good faith.
Event or Problem Description
The importer reported that a user facility reported that their patient sustained a burn and depigmentation at the treatment site following the use of the harmony xl pro system.

• Brand Name: HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, israel 30798 95; IS 3079895
• Manufacturer Contact: odelia zerbiv ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 24868196
• Report Number: 3004167969-2026-00008
• Device Sequence Number: 13269177
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: 17290110120907
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AAHP02110623GAH10001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male