← Back to catalogue

Optilase YAG Model 1000 Surg Laser Sys/Pulmon Appl

FDA 510(k)

Class II (US FDA 510(k))

510(k) K870505

by Trimedyne, Inc.

Identifiers

510(k) Number
K870505 FDA 510(k)
FDA Product Code
LLO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4500 FDA 510(k)
Regulation Number
874.4500 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Neodymium:YAG laser system intended for pulmonary surgery. It is classified as a Class II medical device under regulation number 874.4500 and product code LLO.

The device received FDA 510(k) clearance (K870505) on August 7, 1987, and is substantially equivalent to a predicate device. It is manufactured by Trimedyne, Inc. and is indicated for use in Ear, Nose, and Throat (ENT) procedures as per the advisory committee classification.

Frequently asked questions

What is the Optilase YAG Model 1000 Surgical Laser System used for?

The Optilase YAG Model 1000 is a Neodymium:YAG laser system intended for pulmonary surgery and is indicated for use in Ear, Nose, and Throat (ENT) procedures, as specified in its FDA 510(k) clearance and advisory committee classification.

How is the Optilase YAG Model 1000 supplied and is it reusable?

The device data does not specify whether the Optilase YAG Model 1000 is supplied sterile, single-use, or reusable; therefore, no information about its supply format or reusability can be derived from the provided details.

What regulatory pathway was used for the Optilase YAG Model 1000?

The Optilase YAG Model 1000 received FDA 510(k) clearance (K870505) on August 7, 1987, and was determined to be substantially equivalent to a predicate device under the traditional review pathway.

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: Optilase Yag Model 1000 Surg Laser Sys/Pulmon Appl, Optilase Yag Model 1000 Surgical Laser System, PDF K870505 - Optilase Yag Model 1000 Surg Laser Sys/Pulmon Appl, Optilase Yag Model 1000 Surgical Laser System, Optilase Yag Model 1000 Surgical Laser System 510(k) FDA Premarket ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Trimedyne, Inc.

Sources (1)

  • FDA 510(k) K870505 24 fields · synced Sep 24, 2026