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); Pain (1994); Blister (4537); Hyperpigmentation (4837)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
A user facility reported that a patient underwent a fraxel procedure around the mouth which resulted initially in blisters formation, followed by distinct excoriations and the condition worsening two days post treatment.The patient reported strict avoidance of uv exposure and did not use sunscreen during the exposure period.Secondary treatment was required, and the patient was treated with fucicort® cream.According to information provided, the first photograph showing blister formation was taken on the same day as the treatment in the evening.Three additional photographs were taken two days post treatment, and the photographs show localized burned areas on both sides of the face.At the time of the latest update, the patient¿s condition was reported as improving.There is a potential for residual hyperpigmentation.According to the report, the patient was not receiving any medications at the time of the procedure.The patient is currently improving; however, residual hyperpigmentation is potentially anticipated as a sequela of the event.It was also reported that the patient experienced pain during the treatment.No other treatments (besides the one reported) were being performed in same area where symptoms were reported.The patient's skin type is recorded as type ii-iii.The highest energy used was 20 with a treatment level of 7 and 6 passes.This treatment tip has been used previously 2 times.A burn paper test was not performed prior to using the tip.Due to the reported outcome, the case was reassessed as serious by the medical reviewer.
Additional Manufacturer Narrative
Evaluation of the treatment tip cannot be completed.The system has no system/data logs that can be reviewed.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of acceptable limits.The customer can also utilize the burn paper to confirm the system laser is providing correct pattern/coverage.The customer performed the burn paper test, and the review of the burn paper showed proper pattern/coverage.According to fraxel user manual, discomfort, redness, hyperpigmentation, and burns are known potential reactions to treatment.According to the user manual, blistering or burns may develop over the treated areas.The possibility of temporary and permanent skin color change is known to exist with any laser treatment.Post-inflammatory hypopigmentation and hyper-pigmentation are known complications of many laser treatments and may occur with fraxel laser treatment.Additionally, mild-moderate transient erythema is an expected response.However, if erythema is severe or persists significantly longer than expected, re-treatment should be avoided until the condition resolves.Reaction may vary on a patient-by-patient basis.A review of the manufacturing records showed all requirements were met.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, discomfort, redness, hyperpigmentation, and burns are known potential reactions to fraxel treatment.At this time, no corrective action is necessary.
Event or Problem Description
Updated information of dated pictures demonstrates the first photograph showing blister formation was taken on the same day as the treatment.Three additional photographs were taken 2 days post treatment at the time of this report.The patient¿s condition was reported as improving.There is a potential for residual hyperpigmentation.

• 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: 23900839
• Report Number: 3011423170-2025-00309
• Device Sequence Number: 10116254
• Product Code: GEX
• UDI-Device Identifier: 00816995027263
• UDI-Public: 00816995027263
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/06/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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 Age: 44 YR
• Patient Sex: Female