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FDA PMA

System, photopheresis, extracorporeal

PMA Number: P860003 · 2025-11-21

ApplicantTherakos Development Limited
Decision Date2025-11-21
PMA NumberP860003
Product CodeLNR
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

System, photopheresis, extracorporeal is the device name listed in this FDA 510(k) record. The listed applicant is Therakos Development Limited. It received FDA 510(k) clearance on 2025-11-21. The device is classified under product code LNR. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the System, photopheresis, extracorporeal?

System, photopheresis, extracorporeal is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Therakos Development Limited.

When did System, photopheresis, extracorporeal receive FDA 510(k) clearance?

The clearance date for System, photopheresis, extracorporeal can be found in the official FDA records.

Who is the listed applicant for System, photopheresis, extracorporeal?

The FDA 510(k) record lists Therakos Development Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for System, photopheresis, extracorporeal?

The FDA product code for System, photopheresis, extracorporeal is LNR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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