Data / Medical devices / Light Based Imaging
Light Based Imaging (PSN): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Light Based Imaging (product code PSN, Class 2, 21 CFR 878.4580). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on May 17, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PSN
- Device class
- 2
- Regulation
- 878.4580
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Canada | 1 |
Makers of Light Based Imaging
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Caliber Imaging & Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 2 | May 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| DeepX Health Device Operations | Frisco, TX, United States | Manufacturer | 1 | May 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| MedX Health Corp. | MISSISSAUGA Ontario, Canada | Manufacturer | 1 | September 14, 2007 | 0 | 0 | 0 | api.fda.gov |
Updated May 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.