# Realton (Suzhou) Medical Technology Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 3 (2020–2021): 3 510(k) clearances
- Product codes: GEX (3)
- 510(k) review time since 2016: median 163 days, against 123 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 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
- American Medical Systems, Inc.: 2 (https://510kreport.com/company/american-medical-systems)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)

## Recent decisions
- K202828: Surgical Green Laser System (Jun 4, 2021)
- K202702: FLARE Single-Use Surgical Laser Fiber (Feb 26, 2021)
- K202601: Single-use Sterile medical laser fiber (Dec 15, 2020)

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