Hironic Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hironic Co., Ltd.” (first 2018, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 271 days. Since 2017 the median was 271 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 288 |
| 2019 | 0 | — |
| 2020 | 1 | 405 |
| 2021 | 1 | 477 |
| 2022 | 1 | 507 |
| 2023 | 0 | — |
| 2024 | 2 | 236 |
| 2025 | 1 | 152 |
| 2026 | 2 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hironic Co., Ltd. took a median 271 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 | 1 |
Review panels
Most recent Hironic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | NFO | 2026-08-31 | 206 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | GEI | 2026-04-06 | 59 |
| K251334 | NEW DOUBLO 2.0 | GEI | 2025-09-29 | 152 |
| K241099 | Plasonic (Plasonic) | GEI | 2024-11-08 | 200 |
| K233123 | SILKRO | GEI | 2024-06-24 | 271 |
| K210084 | SILKRO | GEI | 2022-06-03 | 507 |
| K201773 | PICOHI | GEX | 2021-10-19 | 477 |
| K192970 | SLIMUS | PKT | 2020-12-01 | 405 |
| K173676 | A-FIT | GEX | 2018-09-14 | 288 |
Recalls
openFDA lists no recalls under a recalling firm named Hironic Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hironic Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Hironic Co., Ltd.” (first 2018, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hironic Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hironic Co., Ltd. is 271 days. Since 2017: 271 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hironic Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); GEX (Powered Laser Surgical Instrument, 2); NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 1).
Next steps
- See all 9 Hironic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Hironic Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.