# Laser Engineering Heart, Inc.

- Location (FDA's records): Nashville
- FDA decisions: 1 (1998–1998): 1 original PMA approval
- Product codes: MNO (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- P950015: The Heart Laser TM CO2 Laser System for Transmyocardial Revascularization (Aug 20, 1998)

Source page: https://510kreport.com/company/laser-engineering-heart