PSN — Light Based Imaging Class II
FDA product code PSN covers "Light Based Imaging", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |