FDA applicant
Bomtech Electronics Co., Ltd.
FDA records 2 decisions for Bomtech Electronics Co., Ltd. (Seoul, KR) from 2024 to 2025: 2 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and QAI (Powered Microneedle Device). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bomtech Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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