Company ยท KR
Hironic Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2026 | K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) Hironic Co., Ltd., CN | NFO |
| Apr 6, 2026 | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) Hironic Co., Ltd., KR | GEI |
| Sep 29, 2025 | K251334 | NEW DOUBLO 2.0 Hironic Co., Ltd., KR | GEI |
| Nov 8, 2024 | K241099 | Plasonic (Plasonic) Hironic Co., Ltd., KR | GEI |
| Jun 24, 2024 | K233123 | SILKRO Hironic Co., Ltd., KR | GEI |
| Jun 3, 2022 | K210084 | SILKRO Hironic Co., Ltd., KR | GEI |
| Oct 19, 2021 | K201773 | PICOHI Hironic Co., Ltd., KR | GEX |
| Dec 1, 2020 | K192970 | SLIMUS Hironic Co., Ltd., KR | PKT |
| Sep 14, 2018 | K173676 | A-FIT Hironic Co., Ltd., KR | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||