MAUDE Adverse Event Report: Solta Medical, Inc. Thermage FLX (TG-3A) System and Accessories; Electrosurgical,Cutting & Coagulation & Acc.

Model Number	TT4.00F6-900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Skin Discoloration (2074); Skin Erosion (2075); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury

• Brand Name: Thermage FLX (TG-3A) System and Accessories
• Common Device Name: Electrosurgical,Cutting & Coagulation & Acc.
• 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 ; +1(425)420-2135
• MDR Report Key: 50333327
• Report Number: 3011423170-2026-00335
• Device Sequence Number: 5482869
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

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: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown