MAUDE Adverse Event Report: BIOS S.R.L. 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
Investigation bios results: based on the information received: - the device: 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 preventive maintenance was performed since then.Device malfunction wasn't the suspected cause of the adverse event.Incident form - recorded in doc folder; clinical expert report that the injury is serious (rated 8/10) 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 fitzpatrick vi, 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.Possible effects: possible full recovery vs prolonged pigmentary changes vs scarring.Effects are unknown due to gaps in information." rc: root cause not confirmed.Based on the available evidence, no device malfunction was identified.The event is considered most likely related to a use error due to 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 48-72hours prior to a full procedure in the anatomical zone requested for treatment.Additionally, other possible user error components could include: too short pd.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.
Event or Problem Description
Bios, received from the importer lumenis 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 S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer (Section G): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer Contact: edoardo tronchet ; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• MDR Report Key: 24976065
• Report Number: 1720381-2026-00005
• Device Sequence Number: 10480436
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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