510(k) Report

FDA applicant

Omni-Guide Holdings, Inc.

Billerica, MA2 decisions2022–20230 recalls

FDA records 2 decisions for Omni-Guide Holdings, Inc. (Billerica, MA) from 2022 to 2023: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Omni-Guide Holdings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Omni-Guide Holdings, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 20223cite it

What has FDA decided for it lately?

  • K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc. · 2023
  • K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022

All 2 as Omni-Guide Holdings, Inc. →

Other applicant names beginning “Omni-Guide”

FDA records each applicant name separately; these may or may not be the same firm.

Omni Life Science, Inc. 21Omni Intl., Inc. 12Omni Hearing Systems 7Omni Therm, Inc. 5Omni-Tract Surgical, Div. Minn. Scientific, Inc. 4Omni Surgical, L.P. 2Omni Sales Corp. 2Omni Mfg., Inc. 1Omni Medical Designs 1Omni-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1