# K151855: SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Laser Incorporated
- Decided: Apr 15, 2016 after 282 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 401 ancestors in all.
No later device cites it as a predicate yet.
0 of 402 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120810: Fiberoptic Laser Delivery System, Fiberoptic Fabrications, Inc. (2012) Summary page 5.
- K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber, Oberon GmbH Fiber Technologies (2014) Summary page 5.

## Indications for use
The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope. The intended use and clinical applications are described in the User Manual of the corresponding Laser.

Source page: https://510kreport.com/device/K151855
Methodology: https://510kreport.com/methodology