Definition: Intended For Use As A Tool As Part Of A Therapy Regime For The Low Level Light Treatment Of Post Mastectomy Lymphedema And Indicated For Use As A Tool As Part Of A Therapy Regime For The Treatment Of Post Mastectomy Lymphedema.
| Device Type ID | 5480 |
| Device Name | Light, Lymphedema Reduction, Low Energy |
| Physical State | Unit Is A Hand-held Battery Powered Treatment Device, Is Non-thermal And Is Used In The Contact Mode. |
| Technical Method | Device Is Non-thermal And Delivers A Controlled Series Of 200 Ns Bursts Of Pulses Of 904nm Laser Beam, Which Is In The Near Infrared Spectrum That Is Invisible To The Human Eye |
| Target Area | Arms Of Women Who Have Been Treated For Cancer And Have Developed Post Mastectomy Lymphedema |
| Regulation Description | Infrared Lamp. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | General & Plastic Surgery |
| 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 | NZY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5480 |
| Device | Light, Lymphedema Reduction, Low Energy |
| Product Code | NZY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infrared Lamp. |
| CFR Regulation Number | 890.5500 [🔎] |