# Theralase, Inc.

- Location (FDA's records): Markham, Ontario, CA
- FDA decisions: 2 (2005–2015): 2 510(k) clearances
- Product codes: NHN (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Meditech International, Inc.: 1 (https://510kreport.com/company/meditech-international)
- Solica Corporation: 1 (https://510kreport.com/company/solica)

## Its most-cited devices
- K050342: Theralase TLC-1000 Therapeutic Medical Laser System (2005), cited by 2

## Recent decisions
- K151816: TLC-2000 Therapeutic Medical Laser System (Nov 19, 2015)
- K050342: Theralase TLC-1000 Therapeutic Medical Laser System (Jul 11, 2005)

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