Codman Neurolase Laser System
by Codman & Shurtleff, Inc. 510(k)
Active
510(k) K872179
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872179 | Date7 Oct 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Codman Neurolase Laser System is a powered laser surgical instrument. It is designed to perform surgical procedures utilizing laser technology.
This device is identified by FDA 510(k) clearance K872179. It is manufactured by Codman & Shurtleff, Inc. and is classified under product code GEX.
Other devices from Codman & Shurtleff, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the Codman Neurolase Laser System?
The Codman Neurolase Laser System is a powered surgical instrument designed to perform various surgical procedures through the application of laser technology.
How is this device identified for regulatory purposes?
The device is identified by FDA 510(k) clearance number K872179, which indicates that it has been determined to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the Neurolase Laser System?
The Codman Neurolase Laser System is manufactured by Codman & Shurtleff, Inc., located in Randolph, Massachusetts.