MAUDE Adverse Event Report: INMODE LTD. InMode RF Pro system (brand name Luxora) with Quantum handpiece; GEI

Model Number	AG613237A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Peripheral Nervous Injury (4414); Insufficient Information (4580)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinic reported of a female patient sustaining an adverse event following quantum rf procedure, presumably neurapraxia.
Additional Manufacturer Narrative
The treatment provider refused to provide any additional clinical information.It is also unknown what was the exact nature of the adverse event from the received e-mail (not necessarily neurapraxia).Due to lack of information, inmode cannot assess nor investigate the complaint.The clinic updated that the patient is improving.

• Brand Name: InMode RF Pro system (brand name Luxora) with Quantum handpiece
• Common Device Name: GEI
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 50515330
• Report Number: 3010511300-2026-01142
• Device Sequence Number: 9310177
• Product Code: GEI
• UDI-Device Identifier: 07290019863267
• UDI-Public: 07290019863267
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K240780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: AG613237A
• Device Catalogue Number: AG613238A
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 08/24/2025
• 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: Female