Data / Medical devices / South Korea / Bomtech Electronics Co., Ltd.
Bomtech Electronics Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 2 510(k) clearances
Bomtech Electronics Co., Ltd. is registered with the FDA (registration 3007047889) in Seoul, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007047889
- Address
- 322, Gonghang-daero, Gangseo-gu, Seoul, South Korea, 07646
- Owner or operator
- Bomtech Electronics Co., Ltd. (10038846)
- Roles
- Manufacturer
- First device listed
- March 16, 2025
- Registered through
- 2026
- Brand names listed
- E-PEN, JUVPEN MD, REVAFLUX with RF Needle, RM STAR EX with RMS Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2025 | K243143 | E-PEN (E-PEN) | QAI | Substantially Equivalent | Bomtech Electronics Co., Ltd. | accessdata.fda.gov |
| December 26, 2024 | K243097 | RM STAR EX with RMS Needle | GEI | Substantially Equivalent | Bomtech Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Microneedle Device
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated April 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.