Manufacturer registered with FDA
Xenosys Co Ltd
Incheon, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 413 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Xenosys Co Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Xenosys Co Ltd | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | XENOSYS CO., LTD | 7 | 2009–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Xenosys Co Ltd | 3 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Xenosys Co., Ltd. | 3 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Xenosys Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | XDL4 | 2026 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | L2SX5 | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| XENOSYS CO., LTD.FDA reg. 3006799849 | Incheon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023214). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.