Device Type ID | 5947 |
Device Name | System, Non-coherent Light, Photodynamic Therapy |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | MYH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5947 |
Device | System, Non-coherent Light, Photodynamic Therapy |
Product Code | MYH |
FDA Device Classification | Class 3 Medical Device |