RF Medical Co., Ltd.

FDA Regulatory Profile

RF Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 11, 2025 · VAI
Latest 510(k)
Oct 4, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances4Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 11, 2025Geumcheon District, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3015136673

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3015136673Geumcheon District, Korea (The Republic Of)1Sep 11, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K232763Electrode Handpieces (VCT, RFTV, BMDT series)Oct 4, 2023
K221277Mygen M-3004 RF Generator M-3004Sep 2, 2022
K193355Electrodes Handpieces for Mygen V-1000 RF SystemAug 3, 2020
K180999Mygen V-1000 RF SystemDec 11, 2018

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.