PSN
10 FDA 510(k) clearances · Product code
134 daysmedian time to decision
366 days90th percentile
10clearances measured
FDA profile
- Official device name
- Light Based Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- Emission and collection of light to create an image for medical purposes
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DeepX DermoSight Dermatoscope (K230448) | Deepx Health, LLC | 2023-05-17 |
| Demetra Dermatoscope BDEM-01 (K213957) | Barco N.V. | 2022-03-11 |
| Demetra Analytics Toolkit (K201408) | Barco N.V. | 2021-02-18 |
| Demetra BDEM-01 Dermatoscope (K192829) | Barco N.V. | 2019-12-13 |
| VivaScope System (K180162) | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 |
| VIVASCOPE SYSTEM, MODEL 1500, 3000 (K080788) | Lucid, Inc. | 2008-09-17 |
| SIASCOPE V (K062736) | Astron Clinica Limited | 2007-09-14 |
| MICRODERM, MODEL/VERSION 3.5 (K040171) | Visiomed AG | 2004-06-08 |
| SIASCOPE II (K023729) | Astron Clinica Limited | 2003-02-03 |
| SI ASCOPE (K011273) | Astron Clinica Limited | 2002-02-20 |
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