MAUDE Adverse Event Report: LUMENIS BE LTD LIGHTSHEER DESIRE; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information and patient photo.No incident form or patient photo has been received in lumenis.The device was installed on (b)(6) 2015 and last pm was on (b)(6) 2025.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including output energy verification, found all power parameters within lumenis specifications.No device malfunction was observed.The system was operational and was ready for use.Device malfunction wasn't the suspected cause of the adverse event.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis is reporting the event in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.Lumenis is closing this complaint but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4) and per post marketing surveillance procedure (doc no.(b)(4).
Event or Problem Description
Lumenis received an adverse event report on several patients who sustained burns using hs handpiece following treatment by lightsheer desire device.Since no incident form received in lumenis, this complaint will represent all injured patients.

• Brand Name: LIGHTSHEER DESIRE
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer Contact: yossi avnilov ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 23333910
• Report Number: 3021349626-2025-00009
• Device Sequence Number: 8197988
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 7290109140384
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/19/2025

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: LIGHTSHEER DESIRE
• Device Catalogue Number: GA-1170000
• 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: 09/22/2025
• Initial Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown