MAUDE Adverse Event Report: ALMA LASERS LTD ALMA HARMONY CONSOLE WITH GREEN DIODE; POWERED LASER SURGICAL INSTRUMENT

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The importer reported that a user facility reported that a patient sustained a blister at the treatment site following use of the alma harmony system.
Additional Manufacturer Narrative
Clinical evaluation determined that the reported injury is transient in nature and may result in short-term pih in the single spot area.The reported skin reaction is consistent with known and anticipated adverse reactions associated with energy-based treatments, as described in the device labeling.The device was inspected and found to be operating within manufacturer specifications, and no malfunction was identified.Although this event does not meet the criteria for mandatory reporting under 21 cfr part 803, this report is being submitted as a good faith report.

• Brand Name: ALMA HARMONY CONSOLE WITH GREEN DIODE
• 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, 30798 95; IS 3079895
• Manufacturer Contact: odelia zerbiv ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 24679748
• Report Number: 3004167969-2026-00005
• Device Sequence Number: 10003917
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Model Number: 1
• Device Catalogue Number: AAHG25102201BR0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• 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 Sex: Unknown