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 Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is submitted following patient's report to fda mw5182187.The patient reported that the treatment occurred on (b)(6) 2023 and identified the device as secret rf, stating she received a secret radiofrequency treatment three times.The third secret rf treatment was much more painful and caused prolonged tearing.After the swelling went down, cheeks looked flat and the area under eyes appeared sunken.
Additional Manufacturer Narrative
This report is submitted following a patient's complaint to the fda (# mw5182187).The patient incorrectly listed the manufacturer as cutera, the distributor, on report mw5182187, and cutera provided us with the reporting information on february 11, 2026.An unknown 47-year-old hispanic female submitted a voluntary mdr to the fda (mdr no.Mw5182187) on (b)(6) 2026.The patient reported that the treatment occurred on (b)(6) 2023 and identified the device as secret rf, stating she received a secret radiofrequency treatment.She indicated that she underwent a total of three treatments in 2023.The patient did not provide her name, address, or any other identifying or contact information.She also did not identify the facility where the treatment was performed or provide any clinic contact details.As a result, we are unable to further investigate the reported event, as both the patient and the treating clinic are unknown to distributor and manufacturer, and no contact information is available to obtain additional details.According to the distributor's review of clinical incident reports for the secret product family from 2022 to the present, there is no identified report that correlate with the reported timing, geographic location (united states), or the clinical signs and symptoms described by the patient.Based on the available information, this appears to be the first notification of the alleged clinical event.We will continue to monitor future clinical event reports associated with the secret product family for any similar findings.If additional information specific to this case becomes available, we will conduct an appropriate investigation.

• 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: 24553996
• Report Number: 3010363436-2026-00001
• Device Sequence Number: 21164827
• Product Code: GEI
• UDI-Device Identifier: 08800023200171
• UDI-Public: 8800023200171
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: MTR-C1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic
• Patient Race: White