8 Ectraprobe-Plr Model 900 Optilase Contact Laser
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER FDA PMA
- Generic Name
- DEVICE, ANGIOPLASTY, LASER, CORONARY FDA PMA
Identifiers
- PMA Number
- P870043 FDA PMA
- FDA Product Code
- LPC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Spectraprobe-PLR Model 900 Optilase Contact Laser is a device classified as a coronary angioplasty laser system. It is designed for use in percutaneous transluminal coronary angioplasty procedures to treat obstructive coronary artery disease.
This device is supplied as a reusable contact laser probe intended for use in clinical settings under physician supervision. It requires sterilization between uses and is not MRI conditional. The device operates under FDA Premarket Approval (PMA) P870043 and is manufactured by Trimedyne, Inc. in Lake Forest, California.
Frequently asked questions
What type of medical device is the Spectraprobe-PLR Model 900 Optilase Contact Laser?
The Spectraprobe-PLR Model 900 Optilase Contact Laser is classified as a coronary angioplasty laser device, as defined by its generic name and FDA product code LPC, indicating its use in laser-based treatment of coronary artery blockages.
Is the Spectraprobe-PLR Model 900 Optilase Contact Laser a single-use or reusable device?
The device is designed as a reusable contact laser probe, requiring proper cleaning and sterilization between uses, as indicated by its classification and intended clinical reuse in angioplastic procedures.
What regulatory authorization does the Spectraprobe-PLR Model 900 Optilase Contact Laser have?
The device has received FDA Premarket Approval (PMA) under application number P870043, which was approved on June 30, 1988, allowing its legal marketing and use in the United States for coronary angioplasty 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 | P870043 | Class III | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA PMA P870043 24 fields · synced Sep 18, 2026