Product code PSN— General, Plastic Surgery
DeepX DermoSight Dermatoscope
- Classification name
- Light Based Imaging
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 10
- First cleared
- Most recent
FDA classification definition
“Emission and collection of light to create an image for medical purposes”
Market context for product code PSN
FDA has cleared devices under product code PSN between 2002 and 2023, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2022
- 2021
- 2019
- 2018
- 2008
- 2007
- 2004
- 2003
- 2002
Top applicants under product code PSN
Recent clearances under product code PSN
- K230448 — DeepX DermoSight Dermatoscope
- K213957 — Demetra Dermatoscope BDEM-01
- K201408 — Demetra Analytics Toolkit
- K192829 — Demetra BDEM-01 Dermatoscope
- K180162 — VivaScope System
- K080788 — VIVASCOPE SYSTEM, MODEL 1500, 3000
- K062736 — SIASCOPE V
- K040171 — MICRODERM, MODEL/VERSION 3.5
- K023729 — SIASCOPE II
- K011273 — SI ASCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.