Smedtrum Medical Technology Co., Ltd.
TaiwanFDA applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Smedtrum Medical Technology Co., Ltd. makes
Smedtrum Medical Technology Co., Ltd. manufactures laser and light-based systems for dermatological and cosmetic treatments, including intense pulsed light (IPL) devices, CO₂ laser systems, diode laser systems, and picosecond Nd:YAG laser systems. These devices are designed for procedures such as hair removal, skin resurfacing, tattoo removal, and pigmentation treatment.
The company’s portfolio is regulated under Class II medical devices in the US, with devices listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Intense Pulsed Light System Ref K231394
Regimes: 510(k) Registry: 510(k)CO2 Laser System Ref K221597
Regimes: 510(k) Registry: 510(k)Intense Pulsed Light System (ST-690) Ref K240482
Regimes: 510(k) Registry: 510(k)Diode Laser System Ref K230580
Regimes: 510(k) Registry: 510(k)Picosecond Nd:YAG Laser System Ref K240118
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Smedtrum Medical Technology Co. Ltd. New Taipei City · TW FEI 3033482500
Frequently asked questions
How many devices does Smedtrum Medical Technology Co., Ltd. have in the registry?
The registry currently lists 5 devices for Smedtrum Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smedtrum Medical Technology Co., Ltd.'s devices?
Among its 5 most recently registered devices, Smedtrum Medical Technology Co., Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Smedtrum Medical Technology Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Smedtrum Medical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smedtrum Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Smedtrum Medical Technology Co., Ltd. include Intense Pulsed Light System, CO2 Laser System, Intense Pulsed Light System (ST-690) and Diode Laser System.
Which FDA establishments are linked to Smedtrum Medical Technology Co., Ltd.?
1 FDA establishment is linked to Smedtrum Medical Technology Co., Ltd. in the registry; they are listed on the company page.