Trimedyne Laserprobe-Plr Catheter & Optilase
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE FDA PMA
- Generic Name
- Device. Laser peripheral angioplasty FDA PMA
Identifiers
- PMA Number
- P860042 FDA PMA
- FDA Product Code
- LWX FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Trimedyne Laserprobe-Plr Catheter & Optilase is a device classified as a laser peripheral angioplasty system. It is intended for use in cardiovascular procedures to treat peripheral arterial disease using laser energy.
This device is supplied as a catheter and laser system combination, authorized under FDA Premarket Approval (PMA) number P860042. It is a Class III medical device manufactured by Trimedyne, Inc. in Lake Forest, California, and received regulatory approval in February 1987.
Frequently asked questions
What type of medical device is the Trimedyne Laserprobe-Plr Catheter & Optilase?
The device is classified as a laser peripheral angioplasty system, as defined in the specifications under generic_name and openfda device_name, indicating its use in treating peripheral vascular conditions with laser technology.
What regulatory authorization does the Trimedyne Laserprobe-Plr Catheter & Optilase have?
The device has FDA Premarket Approval (PMA) authorization, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P860042 listed in the specifications.
Who manufactures the Trimedyne Laserprobe-Plr Catheter & Optilase and where are they located?
The device is manufactured by Trimedyne, Inc., located at 25901 Commercentre Dr., Lake Forest, CA 92630, as specified in the applicant, city, state, street_1, and zip fields.
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 | P860042 | Class III | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA PMA P860042 24 fields · synced Sep 18, 2026