MAUDE Adverse Event Report: BIOS SRL SPLENDOR X; FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)

Model Number	SPLENDOR X
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/07/2026
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.Incident form has been received in lumenis.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including output energy verification, according to lumenis technical documentation.All of the performed tests passed.No device malfunction was observed.The system was operational and was ready for use.The device was installed on (b)(6) 2024 and no pm was performed since then.Device malfunction wasn't the suspected cause of the adverse event.A lumenis clinical healthcare manager concluded: "lumenis received a report of an adverse event involving the splendor x for laser hair removal.The patient is a female (b)(6), age unknown.This was her fourth treatment, prior treatment on the legs without sequelae.On the date of injury, the patient received laser hair removal on the legs and face.Settings are reported as: lp yag only, 18mm spot size, 10j, pd unspecified, zimmer chiller on 6 (reported via email).A test spot was done on the inner arm 5 mins prior to a full treatment.Treatment was reported as uneventful.During a follow up call 2 days post treatment, the patient reported blistering but did not specify location or a description.The patient is reported to be noncommunicative with the customer and photos were not obtained.Due to lack of photos, pre and postcare, pulse duration, an accurate full assessment is not possible.Root cause failure: unknown- there is known user error with patch testing.The literature states that a patch test should be done 48-72 hours prior to a full procedure in the anatomical zone requested for treatment.Other possible user error components could include: too short pd, improper screening for uv exposure/other contraindications.There are patient variables that are unknown, but possible contributors to this event including: uv exposure, use of skin sensitizing products like retinols, retinoids, exfoliants, compromised skin barrier, uv exposure post treatment.Possible effects: possible full recovery vs prolonged pigmentary changes vs scarring.Effects are unknown due to gaps in information." the hazard severity was rated by clinical director as 8 out of 10 - permanent injury with no impairment.According to the information received there was no device malfunction found.Regarding the clinical evaluation, the cause is not established.Probably the injury caused due to user error, 5 minutes from patch test is not enough time to wait before starting the treatment.The literature states that a patch test should be done 48-72 hours prior to a full procedure in the anatomical zone requested for treatment.Additionally, other possible user error components could include: too short pd, improper screening for uv exposure/other contraindications.There are also patient variables that are unknown, but possible contributors to this event including: uv exposure, use of skin sensitizing products like retinols, retinoids, exfoliants, compromised skin barrier, uv exposure post treatment.Finally the hazard severity was rated as serious injury.Therefore this case was determined as reportable to the fda.Lumenis is not the manufacturer of the splendor x device which was used during this procedure, lumenis has forwarded the information of this event to the legal manufacturer and is closing this complaint.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by splendor x device.

• Brand Name: SPLENDOR X
• Common Device Name: FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)
• Manufacturer (Section D): BIOS SRL; via guido rossa, 10/12; vimodrone, ita 20055 ; IT 20055
• MDR Report Key: 24966351
• Report Number: 3020611964-2026-00006
• Device Sequence Number: 4849796
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2026
• Report Date (Section F): 04/23/2026

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
• Distributor Facility Aware Date: 04/07/2026
• Device Age: 20 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• 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: Female
• Date Report Sent to FDA: 04/23/2026