# Matelaser, Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 2 (2025–2025): 2 510(k) clearances
- Product codes: GEX (1), NVK (1)
- Predicates its devices cite: 1 (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
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)

## Recent decisions
- K250731: MateLaser Medical Diode Laser Systems (ML-DLS-30) (Oct 16, 2025)
- K250195: MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) (May 30, 2025)

Source page: https://510kreport.com/company/matelaser