510(k) Report

FDA applicant

Clinicon Corp.

Carlsbad, CA9 decisions1996–20120 recalls

FDA records 9 decisions for Clinicon Corp. (Carlsbad, CA) from 1996 to 2012: 9 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 15 predicates, 3 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 Clinicon Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument9decisions

Whose devices does it build on?

Its devices cite 15 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 3 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.

  • K962242SurescanClinicon Corp. · 19966cite it
  • K992472Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 19996cite it
  • K014048Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 20022cite it
  • K063698CO2 Laser System, Model C-LasClinicon Corp. · 20071cites it

What has FDA decided for it lately?

  • K121580Surelase CO2 Laser SystemClinicon Corp. · 2012
  • K063698CO2 Laser System, Model C-LasClinicon Corp. · 2007
  • K014236Clinicon Waveguide Platform with Interconnect for Luxar AccessoriesClinicon Corp. · 2002
  • K014048Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
  • K992472Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
  • K983463Surecaut Diamond Laser KnifeClinicon Corp. · 1998
  • K970143C4Clinicon Corp. · 1997
  • K964831SurescanClinicon Corp. · 1997

All 9 as Clinicon Corp. →