Data / Medical devices / Taiwan / Lightmed Dental Technology Corp.
Lightmed Dental Technology Corp.: FDA-registered device maker in Kaohsiung City, Taiwan, 1 510(k) clearance
Lightmed Dental Technology Corp. is registered with the FDA (registration 3013619029) in Kaohsiung City, Taiwan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013619029
- Address
- 5F., No. 96, Luke 5TH RD., Luzhu Dist., Kaohsiung City, Taiwan, 821
- Owner or operator
- LIGHTMED DENTAL TECHNOLOGY CORP. (10079267)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- November 26, 2020
- Registered through
- 2027
- Brand names listed
- SAPPHIRE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| July 25, 2017 | K170073 | LightMed Dental Laser System | GEX | Substantially Equivalent | Lightmed Dentaltechnology Corp. | accessdata.fda.gov |
Compare with other makers
Updated July 25, 2017. 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.