Model 4900 Nd:Yag Laser for Pulmonary Obstructions
by Cooper Lasersonics, Inc. 510(k)
Active
510(k) K880170
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880170 | Date24 Mar 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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
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.
Other devices from Cooper Lasersonics, Inc.
Questions
AI-generated answers, 1 Oct 2026
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.