510(k) Report

FDA applicant

Cardiofocus, Inc.

Norton, MA6 decisions2000–20161 recall

FDA records 6 decisions for Cardiofocus, Inc. (Norton, MA) from 2000 to 2016: 5 510(k) clearances and 1 original PMA approval. Most are in product codes GEX (Powered Laser Surgical Instrument) and OCL (Surgical Device, For Cutting, Coagulation…). Its devices cite 5 predicates, 2 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 Cardiofocus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cardiofocus, 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 Instrument3decisions
  • OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac…1decision
  • DRACatheter, Steerable1decision
  • OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 20014cite it
  • K011988Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 20012cite it
  • K013201Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRCardiofocus, Inc. · 20021cites it
  • K993834Surgical Lightstic, Models, 180 L, and 180 CCardiofocus, Inc. · 20001cites it

What has FDA decided for it lately?

  • P150026Heartlight Endoscopic Ablation SystemCardiofocus, Inc. · 20161 recall
  • K152310HeartLight Deflectable SheathCardiofocus, Inc. · 2016
  • K013201Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRCardiofocus, Inc. · 2002
  • K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
  • K011988Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
  • K993834Surgical Lightstic, Models, 180 L, and 180 CCardiofocus, Inc. · 2000

All 6 as Cardiofocus, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P150026CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It…Feb 7, 2025Class II