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Model 4900 Nd:Yag Laser for Pulmonary Obstructions

by Cooper Lasersonics, Inc. 510(k)

Active United States

510(k) K880170

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880170 Date24 Mar 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a laser, neodymium:Yag, pulmonary surgery instrument. It is classified under FDA product code LLO and is intended for use in pulmonary surgery applications.

It received FDA 510(k) clearance K880170 on March 24, 1988, and is a Class 2 medical device. The device is manufactured by Cooper Lasersonics, Inc. and is designated for use in ear, nose, and throat surgical procedures as indicated by the advisory committee classification.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS used for?

    This device is intended for use in pulmonary surgery applications, specifically within ear, nose, and throat surgical procedures as indicated by its FDA product code LLO and advisory committee classification for ENT.

  • How is the MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS supplied and is it reusable?

    The device is a laser system manufactured by Cooper Lasersonics, Inc., and while the data does not specify sterility or single-use/reuse details, it is a Class 2 medical device cleared under FDA 510(k) K880170, indicating it is intended for clinical use under professional supervision.

  • What regulatory clearance does the MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS have?

    The device received FDA 510(k) clearance under number K880170 on March 24, 1988, and is classified as a Class 2 medical device with product code LLO for laser, neodymium:Yag, pulmonary surgery applications.