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Sign in to claim this brandLaser Engineering Heart, Inc.
US
Last updated May 23, 2026
What Laser Engineering Heart, Inc. makes
Laser Engineering Heart, Inc. manufactures the THE HEART LASER™ CO₂ Tissue Modulation and Removal (TMR) System, a medical device designed for precise laser-based tissue treatment in cardiac procedures.
The company’s portfolio is regulated under FDA Class III requirements and is listed under Premarket Approval (PMA). The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Laser Engineering Heart, Inc. manufacture?
Laser Engineering Heart, Inc. specializes in the THE HEART LASER™ CO₂ Tissue Modulation and Removal (TMR) System, a device designed for laser-based tissue treatment in cardiac procedures. This system is intended for precise medical applications within the heart.
Where is Laser Engineering Heart, Inc. based?
The company is headquartered in the United States. This location influences its regulatory compliance and reporting obligations under U.S. medical device regulations.
How are the devices manufactured by Laser Engineering Heart, Inc. classified by regulatory authorities?
The devices produced by Laser Engineering Heart, Inc., such as THE HEART LASER™, fall under FDA Class III classification. This classification applies to higher-risk devices that require stringent regulatory oversight, including Premarket Approval (PMA) to ensure safety and effectiveness before market authorization.
Which regulatory registries or databases list the devices made by Laser Engineering Heart, Inc.?
The devices from Laser Engineering Heart, Inc. are listed under the FDA’s Premarket Approval (PMA) registry. This registry tracks high-risk medical devices that require approval before commercial distribution in the U.S.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| UltraLase Flexible Laser Waveguide | HWG300-OTO | FDA UDI | Class II | Active |
| Laser Engineering | Aurora MD30 | FDA UDI | Class II | Active |
| Imperium | CO2-300 | FDA UDI | Class II | Active |
| Imperium | CO2-500 | FDA UDI | Class II | Active |
| Laser Engineering | 125MM Handpiece | FDA UDI | Class II | Active |
| UltraLase Flexible Laser Waveguide | HWG300-2.0-3.0 | FDA UDI | Class II | Active |
| UltraLase Flexible Laser Waveguide | HWG500-2.0-3.0 | FDA UDI | Class II | Active |
| Laser Engineering | HWG305-OTO | FDA UDI | Class II | Active |
| Laser Engineering | OTO Handpiece | FDA UDI | Class II | Active |
| Laser Engineering | HWG305 | FDA UDI | Class II | Active |
| UltraLase Flexible Laser Waveguide | HWG505 | FDA UDI | Class II | Active |
| Bipure 1000 | K912347 | FDA 510(k) | Class II | Active |
| Universal Coupler, Laparoscopic Accessory | K912247 | FDA 510(k) | Class II | Active |
| Model Md-45 Co2 Laser For Neurosurgery Use | K881584 | FDA 510(k) | Class II | Active |
| Dual Switch | K141908 | FDA 510(k) | Class II | Active |
| Model Md-25 Laser For Surgical Use | K881588 | FDA 510(k) | Class II | Active |
| Model Md-45 Co2 Laser For Dermatology/Podiatry Use | K881582 | FDA 510(k) | Class II | Active |
| Model Md-45 Co2 Laser For Ent Applications | K881586 | FDA 510(k) | Class II | Active |
| Md Co2 Surgical Laser System/Gen. Surgery And Orth | K905676 | FDA 510(k) | Class II | Active |
| Model Md-45 Co2 Laser For Ob-Gyn & Urological Use | K881581 | FDA 510(k) | Class II | Active |
| Dual Switch | K211605 | FDA 510(k) | Class II | Active |
| Compulse Co2 Surgical Laser Sys. | K911852 | FDA 510(k) | Class II | Active |
| Model Md-25 Co2 Laser For Ear, Nose & Throat | K881583 | FDA 510(k) | Class II | Active |
| Model Md-25 Co2 Laser For Derma./Plastic Surgery | K881580 | FDA 510(k) | Class II | Active |
| Model Md-25 Co2 Laser For Neurosurgery Use | K881585 | FDA 510(k) | Class II | Active |
| Gl-35 Colposcopic Laser System | K875314 | FDA 510(k) | Class II | Active |
| Micromanipulator | K924457 | FDA 510(k) | Class II | Active |
| Model Md-25 Co2 Laser For Podiatry Applications | K881587 | FDA 510(k) | Class II | Active |
| 02-10, 001 | K910062 | FDA 510(k) | Class II | Active |
| The Heart Laser-Tm Co2 Tmr System (the Heart Laser) | P950015 | FDA PMA | Class III | Active |
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