MAUDE Adverse Event Report: CLASSYS INC SECRET RF; MICRO-NEEDLE FRACTIONAL RF

Model Number	MTR-C1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted following patient's complaint to fda (#mw5178360).The patient incorrectly listed the manufacturer as cuterra, the distributor, on report mw5178360, and cuterra provided us with the reporting information on november 22, 2025.The patient underwent a microneedling treatment using the secret rf device at clinic-a on (b)(6) 2024.According to the treating clinic, post-treatment assessment revealed no observed signs of fat loss, facial disfigurement, bruising, contusion, or deformity.The patient later reported that she sought treatment at another clinic-b and underwent a fat transfer procedure in (b)(6) 2025, approximately one year after the secret rf treatment.Based on the procedure report provided by the patient, the pre-operative and post-operative diagnosis at clinic-b was documented as "cosmesis," indicating that the procedure was performed solely for aesthetic purposes, without an underlying pathological condition.The procedure report does not reference alleged fat loss, facial disfigurement, or deformity as the indication for treatment.The patient was presented with available treatment options and elected to proceed with fat transfer.We confirmed with distributor that there was no device malfunction, error message, or abnormal performance was reported from the user facility at the time of the secret rf treatment, (b)(6) 2024.A review of the manufacturing records and inspection results for the secret rf device used during the procedure (serial number: (b)(6) and the associated 25-pin non-insulated tip confirmed that the device met all applicable specifications, with no nonconformities identified.And no similar complaints or adverse events were reported for other devices distributed during the same time period.Based on the information currently available, no causal relationship between the device and the reported event has been identified.We will continue to monitor for similar reports and will reassess if additional information becomes available.
Event or Problem Description
This report is submitted following patient's report to fda mw5178360, claiming "rf microneedling secret rf at a depth of 2 mm on cheeks.It was recommended to me bc i had a scratch on my nose (32 yrs old) left me with fat loss and facial disfigurement.Thousands of dollars in treatment to correct." 1.5 year post secret rf treatment.

• Brand Name: SECRET RF
• Common Device Name: MICRO-NEEDLE FRACTIONAL RF
• Manufacturer (Section D): CLASSYS INC; 208, teheran-ro, gangnam-gu; seoul, 06220 ; KS 06220
• Manufacturer (Section G): CLASSYS INC; 9f; 25, deokcheon-ro 152beon-gil; manan-gu anyang-si, gyeonggi do 14084 ; KS 14084
• Manufacturer Contact: changseop kim ; 208, teheran-ro, gangnam-gu; seoul, 06220 ; KS 06220
• MDR Report Key: 23835104
• Report Number: 3010363436-2025-00001
• Device Sequence Number: 5094052
• Product Code: GEI
• UDI-Device Identifier: 08800023200171
• UDI-Public: 8800023200171
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: MTR-C1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White