Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 PMA record. The listed applicant is Therakos Development Limited. It received FDA Premarket Approval (PMA) on 2025-11-21 under PMA number P860003. The device is classified under FDA product code LNR. It was reviewed by the GU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is System, photopheresis, extracorporeal?

System, photopheresis, extracorporeal is a medical device that received FDA Premarket Approval (PMA) on 2025-11-21. The listed applicant is Therakos Development Limited. The PMA number is P860003.

When did System, photopheresis, extracorporeal receive FDA PMA approval?

System, photopheresis, extracorporeal received FDA PMA approval on 2025-11-21, under PMA number P860003.

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

The FDA PMA record lists Therakos Development Limited as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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

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

What FDA device class is System, photopheresis, extracorporeal?

System, photopheresis, extracorporeal is classified as Class III by the FDA.

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.

↑