Dornier Lasertrode Fiber
by Dornier Surgical Products, Inc. 510(k)
Active
510(k) K991183
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991183 | Date9 Jun 1999 | 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- Withdrawn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, 1 Oct 2026
The Dornier Lasertrode Fiber is a laser surgical instrument accessory that functions as a fiber optic delivery system for laser energy. It is used in conjunction with endoscopic equipment, such as laparoscopes and hysteroscopes, or for open surgery, enabling contact or non-contact delivery of laser energy to soft tissue.
The Dornier Lasertrode Fiber is supplied with FDA 510K authorizations and is classified as a Class 2 General and Plastic Surgery device. It is available in various sizes and designs to meet customer needs and preferences, and is intended for use in laser stone management and other surgical applications.
Other devices from Dornier Surgical Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Dornier Lasertrode Fiber used for?
The Dornier Lasertrode Fiber is used for delivering laser energy to soft tissue during surgical procedures, including laser stone management and other applications.
Is the Dornier Lasertrode Fiber supplied in different sizes?
Yes, the Dornier Lasertrode Fiber is available in various sizes and designs to meet customer needs and preferences.
What type of authorization does the Dornier Lasertrode Fiber have?
The Dornier Lasertrode Fiber has FDA 510K authorization and is classified as a Class 2 General and Plastic Surgery device.