510(k) K230448
- Device
- DeepX DermoSight Dermatoscope
- Applicant
- Deepx Health, LLC
- 510(k) number
- K230448
- Product code
- PSN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-17
- Date received
- 2023-02-21
- Regulation
- 878.4580
- Classification name
- Light Based Imaging
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laurens Kraal
- Address
- 2101 L St., NW - Suite 300 Washington DC US 20037 20037
FDA Registration Numbers#
- 1320925
- 3003725190
- 3042165671
Source Documents#
Other 510(k) Records For Product Code PSN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | 2022-03-11 |
| K201408 | Demetra Analytics Toolkit | Barco N.V. | 2021-02-18 |
| K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019-12-13 |
| K180162 | VivaScope System | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 |
| K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Lucid, Inc. | 2008-09-17 |
| K062736 | SIASCOPE V | Astron Clinica Limited | 2007-09-14 |
| K040171 | MICRODERM, MODEL/VERSION 3.5 | Visiomed AG | 2004-06-08 |
| K023729 | SIASCOPE II | Astron Clinica Limited | 2003-02-03 |
| K011273 | SI ASCOPE | Astron Clinica Limited | 2002-02-20 |