510(k) Report

FDA applicant

Convergent Laser Technologies

Alameda, CA2 decisions1999–20212 recalls

FDA records 2 decisions for Convergent Laser Technologies (Alameda, CA) from 1999 to 2021: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 Convergent Laser Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Convergent Laser Technologies by year, 2007–2026Sources: 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 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K992866Optilite IX Laser Surgery AccessoriesConvergent Laser Technologies · 19992cite it

What has FDA decided for it lately?

  • K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser…Convergent Laser Technologies · 2021
  • K992866Optilite IX Laser Surgery AccessoriesConvergent Laser Technologies · 19992 recalls

All 2 as Convergent Laser Technologies →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K992866OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium…Oct 29, 2017Class III
  • K992866OptiLITE (TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F…Jun 23, 2017Class II

Other applicant names beginning “Convergent”

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

Convergent Dental, Inc. 4Convergent Imaging Solutions 2Convergent Life Sciences, Inc. 1