Data / Medical devices / Japan / Softcare Co., Ltd.
Softcare Co., Ltd.: FDA-registered device maker in Fukutsu Fukuoka, Japan, 1 510(k) clearance
Softcare Co., Ltd. is registered with the FDA (registration 3010792309) in Fukutsu Fukuoka, Japan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010792309
- Address
- 243-5 Yatsunami, Fukutsu Fukuoka, Japan, 811-3201
- Owner or operator
- Softcare Co., Ltd. (10052762)
- Roles
- Manufacturer
- First device listed
- October 5, 2016
- Registered through
- 2026
- Brand names listed
- Laser Speckle Flowgraphy LSFG-NAVI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 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 |
|---|---|---|---|---|---|---|
| May 12, 2016 | K153239 | LSFG-NAVI | HKI | Substantially Equivalent | Softcare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 12, 2016. 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.