510(k) Report

FDA applicant

Laser Dental Innovations

San Jose, CA2 decisions2000–20050 recalls

FDA records 2 decisions for Laser Dental Innovations (San Jose, CA) from 2000 to 2005: 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. 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 Laser Dental Innovations’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Laser Dental Innovations since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Laser Dental Innovations’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 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.

  • K052604Starlite 2006Laser Dental Innovations · 20051cites it
  • K993942Litesaber 2000Laser Dental Innovations · 20001cites it

What has FDA decided for it lately?

  • K052604Starlite 2006Laser Dental Innovations · 2005
  • K993942Litesaber 2000Laser Dental Innovations · 2000

All 2 as Laser Dental Innovations →

Other applicant names beginning “Laser”

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

Laser Industries, Ltd. 20Laser Engineering, Inc. 18L.A.S.E.R., Inc. 14Laser Photonics, Inc. 14Laser Media 13Laser Peripherals, LLC 12Laser-Optik-Systeme GmbH & Co. KG 7Laser Spectrum, Inc. 5Laser Max Medical Technologies Corp. 4Laser Surgical Systems 3Laser Associated Sciences, Inc. 2Laser Endo Technic 2