# K230819: OmniGuide RFID Surgical Laser Fibers

- Pathway: 510(k) (Special)
- Applicant: Omni-Guide Holdings, Inc.
- Decided: Apr 21, 2023 after 28 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.
No later device cites it as a predicate yet.
0 of 404 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 4.

## Indications for use
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser 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 OmniGuide PRIMA Surgical Laser 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/K230819
Methodology: https://510kreport.com/methodology