# Smedtrum Medical Technology Co., Ltd.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 5 (2022–2024): 5 510(k) clearances
- Product codes: GEX (3), ONF (2)
- 510(k) review time since 2016: median 87 days, against 90 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shanghai Apolo Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Alma Lasers, Inc.: 1 (https://510kreport.com/company/alma-lasers)

## Firms that cite its devices most
- Micowey Medical Equipment (Guangxi) Co., Ltd.: 1 (https://510kreport.com/company/micowey-medical-equipment-guangxi)
- Beijing Adss Development Co., Ltd.: 1 (https://510kreport.com/company/beijing-adss-development)

## Its most-cited devices
- K231394: Intense Pulsed Light System (2023), cited by 1
- K240482: Intense Pulsed Light System (ST-690) (2024), cited by 1
- K221597: CO2 Laser System (2022), cited by 1

## Recent decisions
- K240482: Intense Pulsed Light System (ST-690) (May 17, 2024)
- K240118: Picosecond Nd:YAG Laser System (Apr 30, 2024)
- K231394: Intense Pulsed Light System (Aug 9, 2023)
- K230580: Diode Laser System (May 26, 2023)
- K221597: CO2 Laser System (Sep 15, 2022)

Source page: https://510kreport.com/company/smedtrum-medical-technology