Data / Medical devices / South Korea / Hironic Co., Ltd.
Hironic Co., Ltd.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 4 510(k) clearances
Hironic Co., Ltd. is registered with the FDA (registration 3033524168) in Cheongju-si Chungbuk, South Korea. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033524168
- Address
- 190, Osongsaengmyeong 10-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28164
- Owner or operator
- Hironic Co., Ltd. (10058937)
- Roles
- Manufacturer
- First device listed
- February 24, 2023
- Registered through
- 2026
- Brand names listed
- A-FIT RF Needle Tip (Model: A-FIT RN 1.2), A-FIT RF Needle Tip (Model: A-FIT RN 1.5), A-FIT RF Needle Tip (Model: A-FIT RN 1.8), GP Cable, Ground Pad, InPhiuse, NEW DOUBLO 2, PS Handpiece and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | 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 |
|---|---|---|---|---|---|---|
| September 29, 2025 | K251334 | NEW DOUBLO 2.0 | GEI | Substantially Equivalent | Hironic Co., Ltd. | accessdata.fda.gov |
| November 8, 2024 | K241099 | Plasonic (Plasonic) | GEI | Substantially Equivalent | Hironic Co., Ltd. | accessdata.fda.gov |
| June 24, 2024 | K233123 | SILKRO | GEI | Substantially Equivalent | Hironic Co., Ltd. | accessdata.fda.gov |
| June 3, 2022 | K210084 | SILKRO | GEI | Substantially Equivalent | Hironic Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Powered
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Updated September 29, 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.