# K201171: LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable

- Pathway: 510(k) (Traditional)
- Applicant: Leoni Fiber Optics, Inc.
- Decided: Apr 2, 2021 after 336 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). 402 ancestors in all.
No later device cites it as a predicate yet.
0 of 403 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers, Laser Peripherals, LLC (2017) Summary page 4.

## Indications for use
LEONITm Laser Fibers (BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for use in laser-based surgical applications and procedures that are performed with compatible lasers operating at wavelengths between 500nm and 2200nm, which have been cleared.

Source page: https://510kreport.com/device/K201171
Methodology: https://510kreport.com/methodology