Coherent PDL1 and PDL2 Lambda Plus Photodynamic Lasers
FDA PMAby Lumenis Inc.
Identity
- Trade Name
- COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS FDA PMA
- Generic Name
- System, laser, photodynamic therapy FDA PMA
Identifiers
- PMA Number
- P940011 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 PDL1 and PDL2 Lambda Plus Photodynamic Lasers are classified as a System, Laser, Photodynamic Therapy device. These lasers are designed for photodynamic therapy, a treatment modality that uses a photosensitizing agent and light to target and destroy abnormal tissues, such as those affected by certain cancers or vascular lesions. The system leverages specific wavelengths to activate the photosensitizer, inducing a localized cytotoxic reaction in targeted tissues.
These lasers are supplied as a Class III medical device under FDA Premarket Approval (PMA) with PMA number P940011. The devices are intended for use in clinical settings by trained professionals and are not single-use; they require proper maintenance and sterilization procedures between uses. The system operates within the defined parameters of the approved photodynamic therapy applications, adhering to regulatory guidelines for laser safety and efficacy. No additional context regarding MRI safety or specific storage conditions is provided in the data.
Frequently asked questions
What clinical applications are these photodynamic lasers approved for under their FDA Premarket Approval (PMA)?
The Coherent PDL1 and PDL2 Lambda Plus Photodynamic Lasers are FDA PMA-approved for photodynamic therapy, a treatment that combines a photosensitizing agent and specific wavelengths of light to target and destroy abnormal tissues. This includes applications for certain cancers and vascular lesions, though the exact approved uses are defined within the PMA parameters (P940011) and must be followed as outlined in the device’s regulatory documentation.
Are these lasers single-use or reusable, and what maintenance or sterilization procedures are required?
These lasers are not single-use and are designed for repeated clinical use. Since they are Class III devices, they require proper maintenance and sterilization between uses to ensure safety and efficacy. The manufacturer’s instructions (provided by Lumenis) must be followed strictly for cleaning, disinfection, and storage to comply with FDA PMA guidelines (P940011).
What types of medical specialties or clinical settings are these lasers intended for?
The Coherent PDL1 and PDL2 Lambda Plus Photodynamic Lasers are classified under the General, Plastic Surgery advisory committee category (SU) and are intended for use in clinical settings by trained professionals. While the device’s primary applications are in photodynamic therapy, the lack of a specific medical specialty description in the data suggests broad use in procedures requiring laser-activated treatment, such as dermatology, oncology, or vascular surgery.
How do I verify if a specific model or variant of these lasers is compliant with FDA regulations?
Each model variant of the Coherent PDL1 and PDL2 Lambda Plus Photodynamic Lasers is assigned a unique FEI number (e.g., 3002513708, 3006845489) and registration number (e.g., 1226354). To confirm compliance, cross-reference these identifiers with the FDA’s OpenFDA database or the device’s PMA documentation (P940011). The product code MVF also indicates the regulatory classification, but final verification should be done via official FDA records.
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. Sources consulted: Coherent Pdl1 and Pdl2 Lambda Plus Photodynamic Lasers (P940011) — Fda ..., Global Leader in Materials, Networking, and Lasers | Coherent, Premarket Approval (PMA), Coherent Pdl1 and Pdl2 Lambda Plus Photodynamic Lasers Pma P940011 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P940011 | N/A | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Inc.
Sources (1)
- FDA PMA P940011 23 fields · synced Sep 18, 2026