FDA product code PSN: Light Based Imaging
PSN is the FDA product code for light based imaging. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 10 510(k) submissions under PSN, 2 in the last five years, from 6 different applicants. The average 510(k) review took 168 days (median 119).
Definition
Emission and collection of light to create an image for medical purposes
Classification
| Field | Value |
|---|---|
| Device name | Light Based Imaging |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PSN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 104 |
| 2019 | 1 | 72 |
| 2021 | 1 | 266 |
| 2022 | 1 | 84 |
| 2023 | 1 | 85 |
Compare with all 510(k) review times · Search every PSN clearance
Top PSN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Barco N.V. | 3 | 2022-03-11 |
| Astron Clinica Limited | 3 | 2007-09-14 |
| Deepx Health, LLC | 1 | 2023-05-17 |
| Caliber Imaging & Diagnostics, Inc. | 1 | 2018-05-03 |
| Lucid, Inc. | 1 | 2008-09-17 |
1 more applicants have PSN clearances. See the full list in Caduvo.
Most recent PSN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230448 | Deepx Health, LLC | DeepX DermoSight Dermatoscope | 2023-05-17 | 85 |
| K213957 | Barco N.V. | Demetra Dermatoscope BDEM-01 | 2022-03-11 | 84 |
| K201408 | Barco N.V. | Demetra Analytics Toolkit | 2021-02-18 | 266 |
| K192829 | Barco N.V. | Demetra BDEM-01 Dermatoscope | 2019-12-13 | 72 |
| K180162 | Caliber Imaging & Diagnostics, Inc. | VivaScope System | 2018-05-03 | 104 |
Recalls for PSN devices
openFDA lists no recalls for product code PSN.
Frequently asked questions
What is FDA product code PSN?
PSN is the FDA product code for light based imaging. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is PSN?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k).
How long does a 510(k) take for product code PSN?
Across 10 cleared submissions the average was 168 days from receipt to decision (median 119).
Which companies have the most PSN clearances?
Barco N.V. (3); Astron Clinica Limited (3); Deepx Health, LLC (1); Caliber Imaging & Diagnostics, Inc. (1); Lucid, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PSN
- Run a recall and safety report across every PSN manufacturer
- Watch product code PSN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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