MAUDE Adverse Event Report: Lumenis Be Ltd Splendor X; Family of Square Epil (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

Model Number	Splendor X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by spx device.

• Brand Name: Splendor X
• Common Device Name: Family of Square Epil (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
• Manufacturer (Section D): Lumenis Be Ltd; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• MDR Report Key: 50751870
• Report Number: 3020611964-2026-00011
• Device Sequence Number: 13339440
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Other
• Device Model Number: Splendor X
• Device Catalogue Number: GA-5000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• 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
• Date Report Sent to FDA: 09/14/2026