# K232106: Air Gap Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Jan 8, 2024 after 178 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 6.

## Indications for use
The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.

Source page: https://510kreport.com/device/K232106
Methodology: https://510kreport.com/methodology