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Diomed 630 PDT Laser, Model T2USA

FDA PMA

Class III (US FDA PMA)

PMA P990021

by Pinnacle Biologics, Inc.

Identity

Trade Name
DIOMED 630 PDT LASER FDA PMA
Generic Name
System, laser, photodynamic therapy FDA PMA

Identifiers

PMA Number
P990021 FDA PMA
FDA Product Code
MVF FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA

The Diomed 630 PDT Laser is a photodynamic therapy system designed for activation of Photofrin (Porfimer Sodium) in clinical applications. Classified as a System, Laser, Photodynamic Therapy, it delivers targeted light energy to treat obstructive esophageal cancer, either fully or partially obstructing, when conventional Nd:YAG laser therapy is deemed unsuitable by the treating physician.

This device is supplied as a reusable medical instrument and is regulated under FDA_PMA (Premarket Approval) with PMA number P990021. It is intended for use in surgical settings, where it is activated with Photofrin to palliate symptoms in patients with obstructing esophageal cancer. The system operates under strict regulatory oversight, adhering to Device Class 3 standards and approved for specific indications as outlined in the PMA filing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Pinnacle Biologics, Inc.

Sources (1)

  • FDA PMA P990021 24 fields · synced Oct 6, 2026