Light Based Imaging
The Light Based Imaging device is a surgical imaging device that emits and collects light to create medical images, used in the General and Plastic Surgery specialty to provide visual information during surgical procedures. It is classified as FDA Class 2 under 21 CFR 878.4580, requiring 510(k) premarket notification, and is eligible for third-party review. Product code PSN; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PSN
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Emission and collection of light to create an image for medical purposes
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230448 | DeepX DermoSight Dermatoscope | May 17, 2023 | Substantially Equivalent | Deepx Health, LLC |
| K213957 | Demetra Dermatoscope BDEM-01 | Mar 11, 2022 | Substantially Equivalent | Barco N.V. |
| K201408 | Demetra Analytics Toolkit | Feb 18, 2021 | Substantially Equivalent | Barco N.V. |
| K192829 | Demetra BDEM-01 Dermatoscope | Dec 13, 2019 | Substantially Equivalent | Barco N.V. |
| K180162 | VivaScope System | May 03, 2018 | Substantially Equivalent | Caliber Imaging & Diagnostics, Inc. |
| K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Sep 17, 2008 | Substantially Equivalent | Lucid, Inc. |
| K062736 | SIASCOPE V | Sep 14, 2007 | Substantially Equivalent | Astron Clinica Limited |
| K040171 | MICRODERM, MODEL/VERSION 3.5 | Jun 08, 2004 | Substantially Equivalent | Visiomed AG |
| K023729 | SIASCOPE II | Feb 03, 2003 | Substantially Equivalent | Astron Clinica Limited |
| K011273 | SI ASCOPE | Feb 20, 2002 | Substantially Equivalent | Astron Clinica Limited |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.