MAUDE Adverse Event Report: SOLTA MEDICAL, INC. FRAXEL DUAL 1550/1927 LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	MCSYS-SR1500D-INTL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event was reported eight months after its occurrence.No product was returned for evaluation at the time of the event.In a separate instance, the provider¿s device was serviced and repaired seven months after the reported adverse event for event code 122 (invalidtrackingid).Service confirmed the event code and found that the mouse assembly was not working, which was causing the event code.If the system detects an event code, the system will stop energy delivery until the error is resolved or the system is repaired.There is no risk to patients due to the reported event code that occurred months after the reported adverse event.Service replaced the mouse assembly, resolving the event code.The system passed electrical safety, system and power cycle tests.Review of device manufacturing records did not reveal any concerns.Final test verification specifications are acceptable.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 are considered acceptable, with the product performing within anticipated rates.According to the fraxel user manual, burns and blisters are known potential reactions to fraxel treatment.Blistering or burns may develop over the treated areas.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.No corrective action is necessary at this time.
Event or Problem Description
A patient experienced a burn on the right forehead near the hairline one day after a fraxel dual treatment.There was no overlapping of passes during the treatment.The tip had been used on one other patient.A burn paper test was performed prior to the treatment with good results.For 1550, the highest energy level used/ percent coverage was 20/4, with 4 passes completed.For 1927 the highest energy level used/ percent coverage was 15/2, with 4 passes completed.No system errors or anything out of the ordinary occurred during the treatment.However, when the event was reported eight months later, the doctor expressed concerns with their fraxel system referencing a required repair and this adverse event that occurred during system training.The patient regularly takes vitamin d and uses topical cleanser, moisturizer, and sunscreen.The patient had stopped retinol aha/bha two weeks prior to treatment.No other treatments were being performed in the same area where device symptoms were reported.The patient had received neuromodulators and platelet-rich plasma approximately two months prior to treatment.The patient had received venus viva (radiofrequency), intense pulsed light, and bela md approximately one year and two years prior to the fraxel treatment.The patient has skin type iii and experienced minimal sun exposure post healing and used sunscreen after the treatment.The wound was covered with bactroban.The patient¿s status was good approximately ten months and one-week post-treatment, yet a small scar remains on the right forehead.Though requested, no additional event or patient information or photos were provided.

• Brand Name: FRAXEL DUAL 1550/1927 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: 24389998
• Report Number: 3011423170-2026-00313
• Device Sequence Number: 18771254
• Product Code: GEX
• UDI-Device Identifier: 00816995027263
• UDI-Public: 00816995027263
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: MCSYS-SR1500D-INTL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: Unknown