Optiguide Fiber Optic Diffuser (Dcyl Cylindrical Diffuser Series)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER FDA PMA
- Generic Name
- System, laser, fiber optic, photodynamic therapy FDA PMA
Identifiers
- PMA Number
- P940010 FDA PMA
- FDA Product Code
- MVG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Optiguide Fiber Optic Diffuser is a system, laser, fiber optic, photodynamic therapy device. It is designed for use in delivering laser energy in photodynamic therapy applications.
This device is supplied as a reusable component and is intended for use in clinical settings such as general and plastic surgery. It has received FDA PMA approval (P940010) and is authorized for the specific models DCYL 10, DCYL 15, and DCYL 25.
Frequently asked questions
What is the Optiguide Fiber Optic Diffuser used for?
The Optiguide Fiber Optic Diffuser is a system, laser, fiber optic, photodynamic therapy device designed for delivering laser energy in photodynamic therapy applications, as indicated by its generic name and device classification in the provided data.
Which models of the Optiguide Fiber Optic Diffuser are covered by the FDA PMA approval?
The FDA PMA approval (P940010) specifically covers the Optiguide Fiber Optic Diffuser models DCYL 10, DCYL 15, and DCYL 25, as stated in the AO statement within the device data.
Is the Optiguide Fiber Optic Diffuser a single-use or reusable device?
The device is supplied as a reusable component, based on the device type and specifications provided, which describe it as a system intended for repeated use in photodynamic therapy procedures.
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 | P940010 | Class III | Active |
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Manufacturer
- Manufacturer
- Pinnacle Biologics, Inc.
Sources (1)
- FDA PMA P940010 23 fields · synced Oct 6, 2026