Definition: Emission And Collection Of Light To Create An Image For Medical Purposes
| Device Type ID | 5876 |
| Device Name | Light Based Imaging |
| Physical State | Device Is A Light Source In A Housing And Light Detectors In A Housing That Can Be Aimed At A Target Tissue |
| Technical Method | Device Emits Light That Is Collected From The Target Tissue And Then Analyzed To Provide Information About The Target |
| Target Area | Intact Human Skin |
| Regulation Description | Surgical Lamp. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 510(k) |
| CFR Regulation Number | 878.4580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5876 |
| Device | Light Based Imaging |
| Product Code | PSN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CALIBER IMAGING & DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |