PSN — Light Based Imaging Class II
Classification Details
- Product Code
- PSN
- Device Class
- Class II
- Regulation Number
- 878.4580
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Emission and collection of light to create an image for medical purposes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230448 | deepx health | DeepX DermoSight Dermatoscope | May 17, 2023 |
| K213957 | barco n.v | Demetra Dermatoscope BDEM-01 | March 11, 2022 |
| K201408 | barco n.v | Demetra Analytics Toolkit | February 18, 2021 |
| K192829 | barco n.v | Demetra BDEM-01 Dermatoscope | December 13, 2019 |
| K180162 | caliber imaging and diagnostics | VivaScope System | May 3, 2018 |
| K080788 | lucid | VIVASCOPE SYSTEM, MODEL 1500, 3000 | September 17, 2008 |
| K062736 | astron clinica limited | SIASCOPE V | September 14, 2007 |
| K040171 | visiomed | MICRODERM, MODEL/VERSION 3.5 | June 8, 2004 |
| K023729 | astron clinica limited | SIASCOPE II | February 3, 2003 |
| K011273 | astron clinica limited | SI ASCOPE | February 20, 2002 |