Radial-Emitting Shaped Fiber Optic Delivery System
510(k) K110080
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110080 | Date24 Feb 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 19 Sep 2026
The Radial-Emitting Shaped Fiber Optic Delivery System is a fiber optic device designed for laser-based surgical procedures. It delivers laser energy radially through a shaped fiber, enabling precise incision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue in both contact and non-contact modes, including open and closed endoscopic applications.
This system is supplied as a reusable medical device and is intended for use with surgical lasers featuring an SMA 905-compatible connector. It is regulated under the FDA’s 510(k) clearance pathway (K110080) and falls under the General, Plastic Surgery advisory committee category. The device is not classified as single-use and requires proper handling and sterilization as per manufacturer guidelines.