Coherent Opal Photoactivator Laser System
FDA PMAClass III (US FDA PMA)
by Lumenis
Identity
- Trade Name
- COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM FDA PMA
- Generic Name
- System, laser, photodynamic therapy FDA PMA
Identifiers
- PMA Number
- P990049 FDA PMA
- FDA Product Code
- MVF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APWD FDA PMA
The Coherent Opal Photoactivator Laser System is a photodynamic therapy laser system designed for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. This device utilizes laser technology to activate photosensitive compounds for therapeutic purposes.
The system is manufactured by Lumenis and is authorized for use in medical settings. It is a Class III medical device with FDA PMA approval. The device is supplied as a complete system and should be used according to the manufacturer's instructions for proper operation and patient safety.
Frequently asked questions
What conditions does the Coherent Opal Photoactivator Laser System treat?
The Coherent Opal Photoactivator Laser System is specifically approved for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. It is not indicated for other conditions or uses beyond this specific application.
What is the regulatory status of the Coherent Opal Photoactivator Laser System?
The Coherent Opal Photoactivator Laser System is a Class III medical device that has received FDA PMA (Premarket Approval) with the approval number P990049. This indicates it has undergone rigorous review by the FDA and is deemed safe and effective for its intended use when used according to the approved indications.
How is the Coherent Opal Photoactivator Laser System used in photodynamic therapy?
The Coherent Opal Photoactivator Laser System is used as part of a photodynamic therapy treatment process. It delivers laser light to activate photosensitive compounds that have been administered to the patient. The laser light activates these compounds to produce a therapeutic effect on the targeted tissue, specifically in the treatment of age-related macular degeneration with predominantly classic subfoveal choroidal neovascularization.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990049 | Class III | Active |
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Manufacturer
- Manufacturer
- Lumenis
Sources (1)
- FDA PMA P990049 24 fields · synced Sep 18, 2026