# K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Feb 14, 2025 after 252 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: 24 generations back to K943450 (1995). 403 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 406 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220189: LISA Laser Surgical Fibers, Omni-Guide Holdings, Inc. (2022) Summary page 6.

## Most influential descendants
- K252745: Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) (2025), 1 descendant of its own
- K261701: Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) (2026), 0 descendants of its own

## Indications for use
WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

Source page: https://510kreport.com/device/K241643
Methodology: https://510kreport.com/methodology