Medical Laser Products
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| 1032 | System, Laser, Transmyocardial Revascularization |
| 1032 | System, Laser, Transmyocardial Revascularization |
| System, Laser, Transmyocardial Revascularization [32410] | 21 CFR Unclassified 🔎 |
| System, Laser, Transmyocardial Revascularization [32150] | 21 CFR Unclassified 🔎 |
| P950015 | THE HEART LASER(TM)CO2 TMR SYSTEM | Laser Engineering Heart Inc. |
| P970029 | TMR Holmium Laser System | CRYOLIFE, INC. |
| 00877234000119 | System, Laser, Transmyocardial Revascularization |
| 00877234000102 | System, Laser, Transmyocardial Revascularization |
| 00877234000096 | System, Laser, Transmyocardial Revascularization |
| 00860701000101 | System, Laser, Transmyocardial Revascularization |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2019-05-03 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. ? KENNESAW | 2019-04-16 |
| TEST FIBER | CRYOLIFE, INC. | 2018-12-10 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. ? KENNESAW | 2018-10-17 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-10-16 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-10-16 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-05-17 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-05-17 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-05-17 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-05-15 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-05-15 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2018-04-24 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-10-27 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-08-31 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-08-15 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-07-26 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-07-05 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-06-02 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-03-08 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-03-01 |
| SOLOGRIP III HANDPIECE | CRYOLIFE INC | 2017-02-20 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-02-13 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2017-02-02 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2016-12-27 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2016-06-14 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2016-05-20 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2016-04-14 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2016-02-01 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2016-01-22 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-11-17 |
| SOLARGEN III HANDPIECE | CRYOLIFE, INC. | 2015-09-22 |
| SOLARGEN 2100S CONSOLE | CRYOLIFE, INC. | 2015-09-16 |
| SOLARGEN 2100S CONSOLE | CRYOLIFE, INC. | 2015-07-22 |
| SOLARGEN 2100S CONSOLE | CRYOLIFE, INC. | 2015-06-09 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-05-19 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-04-23 |
| SOLARGEN 2100S CONSOLE | CRYOLIFE, INC. | 2015-04-13 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-04-07 |
| TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CRYOLIFE, INC. | 2015-03-27 |
| PHOENIX HANDPIECE | CRYOLIFE, INC. | 2015-02-12 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-01-22 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-01-16 |
| SOLOGRIP III HANDPIECE | CRYOLIFE, INC. | 2015-01-16 |
| SOLARGEN 2100S TRANSYMOCARDIAL REVASCULARIZATION LASER CONSOLE | CARDIOGENESIS CORPORATION | 2014-12-22 |
| TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CARDIOGENESIS CORPORATION | 2014-12-22 |
| SOLOGRIP III HANDPIECE | CARDIOGENESIS CORPORATION | 2014-11-19 |
| SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CARDIOGENESIS CORPORATION | 2014-10-03 |
| TMR2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CARDIOGENESIS CORPORATION | 2014-10-01 |
| PEARL 5.0 HANDPIECE | CARDIOGENESIS CORPORATION | 2014-09-22 |
| PEARL 5.0 HANDPIECE | CARDIOGENESIS CORPORATION | 2014-09-22 |