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RF Medical Co., Ltd.

FDA Regulatory Profile

RF Medical Co., Ltd. appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Sep 11, 2025 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Oct 4, 2023.

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Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent FDA Inspections

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

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

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

FDA data resources