510(k) Report

FDA applicant

Omniguide, Inc.

Cambridge, MA14 decisions2006–20211 recall

FDA records 14 decisions for Omniguide, Inc. (Cambridge, MA) from 2006 to 2021: 14 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 73 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 13 of them its own earlier devices. 1 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 Omniguide, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 32008: 22009: 22014: 12018: 12019: 12021: 1
2007high 3 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Omniguide, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Omniguide, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument14decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 73 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 34 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 13 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.

  • K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 20074cite it
  • K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc. · 20092cite it
  • K081939Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc. · 20082cite it
  • K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 20082cite it
  • K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 20141cites it
  • K062423Omniguide Beampath Laser Beam Delivery SystemOmniguide, Inc. · 20061cites it

What has FDA decided for it lately?

  • K203241OmniGuide BeamPath OTO-U FiberOmniguide, Inc. · 2021
  • K183199TRIO HandpieceOmniguide, Inc. · 2019
  • K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc. · 2018
  • K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014
  • K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc. · 2009
  • K093251Omniguide Beampath Fels 25A CO2 Laser SystemOmniguide, Inc. · 2009
  • K081939Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc. · 2008
  • K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008

All 14 as Omniguide, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070157OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide…Nov 5, 2012Class II

Other applicant names beginning “Omniguide”

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

Omniguide Communications, Inc. 1