MAUDE Adverse Event Report: LUMENIS BE LTD STELLAR M22; POWERED LASER SURGICAL INSTRUMENT

Model Number	STELLAR M22 LMX , AES
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2025
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.The customer reported on last 3 patients have had swelling and 2 needed medical help.However, since no incident form or photos were sent to lumenis, clinical evaluation wasn't performed.The device ga-0006200lmxbe: (b)(6) was installed in the facility on (b)(6) 2024 and the most recent pm was done on (b)(6) 2024.This device is under contract.An examination of the subject device was performed by lumenis service engineer after verifying all system functions.Visually inspected ipl handpiece, lightguides and filters.Small burn seen inside of handpiece.Carried out energy check in line with present system checklist.Output energy from the ipl handpiece was within expected range and no fault could be found.Handpiece to be replaced due to the burn inside the hp as a precaution.Device malfunction wasn't the suspected cause of the adverse event.Since device malfunction wasn't the suspected cause of the adverse event, this case is not-reportable to the uk mhra.The referred decision tree was approved via email.Lumenis asked customer several times to provide us a filled-out incident form or/and photo, but the customer didn't respond.Since no essential information was received within period which is determined for reportability, lumenis is reporting this event to the fda in an 'abundance of caution'.Due to lack of information the root cause of the ae was not established.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
Lumenis received an adverse event report on several patients who sustained swelling following treatment by stellar device.However, since the customer didn't provide us even one incident form, this case will be evaluated in current single complaint.

• Brand Name: STELLAR M22
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: roman vernik ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 23507765
• Report Number: 3021349626-2025-00010
• Device Sequence Number: 18401537
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193500
• 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: 505
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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: Other
• Device Model Number: STELLAR M22 LMX , AES
• Device Catalogue Number: GA-0006200LMXBE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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