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

Catalog Number	AAHG25102201BR0002
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation determined the reported injury was a transient first-degree burn, consistent with a known ipl treatment-related adverse reaction, that is expected to resolve without permanent impairment; although the event does not meet the definition of a serious injury under 21 cfr part 803, it is being reported in good faith.The returned handpiece was evaluated (by our importer).Energy output was within specification.During service evaluation, a cooling component malfunction was identified and corrected.Post-repair testing confirmed the device met manufacturer specifications.Review of the available information indicated use of the dye vl applicator for treatment of a pigmented lesion and treatment parameters that may not have been adequately adjusted based on patient response.Based on the available evidence, the most probable cause of the event was user-related, including treatment parameter selection and/or treatment technique.A causal relationship between the identified cooling component malfunction and the reported injury could not be established.
Event or Problem Description
Importer reported that user facility reported that a patient sustained a burn at the treatment site following use of the alma harmony system.

• 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: 25589708
• Report Number: 3004167969-2026-00010
• Device Sequence Number: 9995195
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K230308
• 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): 06/23/2026

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: AAHG25102201BR0002
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/23/2026
• 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: Female