Data / Medical devices / South Korea / Classys Inc
Classys Inc: FDA-registered device maker in Republic of Korea Seoul, South Korea, 2 510(k) clearances
Classys Inc is registered with the FDA (registration 3012259264) in Republic of Korea Seoul, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012259264
- Address
- 208, Teheran-ro, Gangnam-gu, Republic of Korea Seoul, South Korea, 06220
- Owner or operator
- CLASSYS INC (10051595)
- Roles
- Manufacturer
- First device listed
- December 15, 2023
- Registered through
- 2026
- Brand names listed
- SCIZER, Volnewmer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | 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 29, 2024 | K240248 | Volnewmer | GEI | Substantially Equivalent | Classys, Inc. | accessdata.fda.gov |
| November 3, 2023 | K230100 | SCIZER (SC1-M410) | OHV | Substantially Equivalent | Classys, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated April 29, 2024. 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.