# K220189: LISA Laser Surgical Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Omni-Guide Holdings, Inc.
- Decided: Apr 29, 2022 after 95 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.
5 later devices descend from it; 3 cite it directly.
0 of 408 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 5.

## Most influential descendants
- K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (2025), 2 descendants of its own
- 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
- K230819: OmniGuide RFID Surgical Laser Fibers (2023), 0 descendants of its own
- K220793: InnoVoyce Laser Fiber (2022), 0 descendants of its own

## Indications for use
Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm — 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.

Source page: https://510kreport.com/device/K220189
Methodology: https://510kreport.com/methodology