Data / Medical devices / Taiwan / Smedtrum Medical Technology Co. Ltd.
Smedtrum Medical Technology Co. Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 5 510(k) clearances
Smedtrum Medical Technology Co. Ltd. is registered with the FDA (registration 3033482500) in New Taipei City, Taiwan. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033482500
- Address
- 1F., No. 8, Ln. 97, Wugong Rd. Xinzhuang Dist., New Taipei City, Taiwan, 248016
- Owner or operator
- Smedtrum Medical Technology CO. Ltd. (10091720)
- Roles
- Manufacturer
- First device listed
- November 21, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 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 17, 2024 | K240482 | Intense Pulsed Light System (ST-690) | ONF | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 30, 2024 | K240118 | Picosecond Nd:YAG Laser System | GEX | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 9, 2023 | K231394 | Intense Pulsed Light System | ONF | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 26, 2023 | K230580 | Diode Laser System | GEX | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 15, 2022 | K221597 | CO2 Laser System | GEX | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated May 17, 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.