FDA Product Code
FDA Product Code PSN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4580
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | 2023-05-17 | Traditional | PDF ↗ |
| K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | 2022-03-11 | Special | PDF ↗ |
| K201408 | Demetra Analytics Toolkit | Barco N.V. | 2021-02-18 | Traditional | PDF ↗ |
| K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019-12-13 | Traditional | PDF ↗ |
| K180162 | VivaScope System | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 | Special | PDF ↗ |
| K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Lucid, Inc. | 2008-09-17 | Traditional | PDF ↗ |
| K062736 | SIASCOPE V | Astron Clinica Limited | 2007-09-14 | Traditional | PDF ↗ |
| K040171 | MICRODERM, MODEL/VERSION 3.5 | Visiomed AG | 2004-06-08 | Traditional | PDF ↗ |
| K023729 | SIASCOPE II | Astron Clinica Limited | 2003-02-03 | Traditional | PDF ↗ |
| K011273 | SI ASCOPE | Astron Clinica Limited | 2002-02-20 | Traditional | PDF ↗ |
Product code PSN · Class II · General, Plastic Surgery. Data: openFDA.