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	Seroma (2069); Nodule (4551); Hyperpigmentation (4837)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient first underwent quantum procedure on her pubic region and developed a seroma.Additionally, the patient was treated on her medial thigh with quantum rf, where a nodule was later observed.Per latest update, the nodule resolved with pih as a sequela.
Additional Manufacturer Narrative
Investigation is ongoing.Inmode will submit a supplementary report upon completion of the investigation.This report is submitted in compliance with fda regulations at 21 cfr part 803 and should not be considered to be an admission that any inmode product is defective or caused serious injury.

• 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: 50515323
• Report Number: 3010511300-2026-01137
• Device Sequence Number: 21159668
• 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: Other,Inspection,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: Required Intervention; Other
• Patient Sex: Female
• Patient Race: White