Definition: A LASER (Light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. This Device Emits Energy In The Infrared Or Other Wavelengths, Provides Non-heating And Non-thermal Eff
| Device Type ID | 5228 |
| Device Name | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Regulation Description | Infrared Lamp. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.5500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5228 |
| Device | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Product Code | NHN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infrared Lamp. |
| CFR Regulation Number | 890.5500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ERCHONIA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ERCHONIA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERCHONIA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERALASE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |