MAUDE Adverse Event Report: SOLTA MEDICAL, INC. FRAXEL FTX LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	MCSYSFTX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Discoloration (2074); Hyperpigmentation (4837)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported hyperpigmentation and redness in the cheek area 8 weeks post fraxel ftx treatment.Approximately four days after a facial and cheek area procedure, the patient experienced noticeable redness on the cheeks, which progressed to brown discoloration and darkened further within 1¿2 weeks.The nature of the injury was reported as post-inflammatory hyperpigmentation/redness.Treatment included alastin nectar and stratacel scar gel.The current status was reported as persistent cheek discoloration with a visible demarcation line under the eyes corresponding to the laser treatment boundary.Available images of the patient¿s face were reviewed by the medical reviewer.A total of seven undated images was provided, showing varying views of the patient¿s face.Some of these images depict minor discoloration on the cheekbones and the nasal bridge.The outcome was noted as discoloration.Based on available information indicating that permanent discoloration is expected, the case was reassessed as serious.No other treatments (besides the one reported) were being performed in the same area where the symptoms were reported.The patient has had prior aesthetic treatments on this area, which include: lutronic lasemd, skin pen microneedling, neo aerolase sporadically.These were performed months prior to the fraxel treatment.Skin care products (lotions, sunscreen, etc.) before treatment included skin better alpha ret and glymed mandelic acid cleanser (stopped 2 weeks prior).Skin care products immediately after treatment included elta laser enzyme gel.Skin care post treatment included nectar, neova copper peptide mask, and neova copper peptide lotion.There was no sun exposure during healing and post healing.The patient did utilize sunscreen during the exposure.The skin type for the patient was recorded as type 3.For wavelength 1550, the highest energy level used was 10j, 3% percent coverage, and 4 number of passes completed.For wavelength 1927, the highest energy level used was 10j, 1% percent coverage, and 4 number of passes completed.10j, 1% coverage, 4 passes.No system errors occurred, nor was anything out of the ordinary noticed during treatment.The tip used in this treatment, has not been used to treat other patients.A burn paper test was not performed prior to using the tip.It was reported a zimmer cooling unit was used was used during treatment.
Additional Manufacturer Narrative
The datacard log was returned for evaluation.Evaluation of the logs found no issues related to this event.Additionally, the system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.The customer performed the burn paper test and sent it in for review.The review of the burn paper showed proper pattern/coverage.The treatment tips do not delivery any energy and no treatment data is stored on the tip itself; there is no information to gather from their return.The exception to this would be if the tips plastic housing or component scratched the patient, which did not happen in this case.For other reported events, tips are not a viable source of evaluation data.According to fraxel ftx user manual, redness and discoloration are known potential reactions to treatment.The possibility of temporary and permanent skin color change is possible with any laser treatment.Post-inflammatory hypopigmentation and hyperpigmentation are known complications of many laser treatments and may occur with the fraxel laser system.Following appropriate instructions for sun protection will lower the risk of pigmentation changes.A review of the manufacturing records showed all requirements were met.No nonconformities or anomalies were found related to this event when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this event is known reaction to treatment.At this time, no capa is necessary.

• Brand Name: FRAXEL FTX LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 22867159
• Report Number: 3011423170-2025-00296
• Device Sequence Number: 9175526
• Product Code: GEX
• UDI-Device Identifier: 00816995027805
• UDI-Public: 00816995027805
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K242142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: MCSYSFTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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
• Patient Sex: Female