510(k) Report

FDA applicant

Intelligent Surgical Lasers, Inc.

San Diego, CA2 decisions1989–19940 recalls

FDA records 2 decisions for Intelligent Surgical Lasers, Inc. (San Diego, CA) from 1989 to 1994: 2 510(k) clearances. Most are in product codes LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior…) and GEX (Powered Laser Surgical Instrument). 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, ophthalmic panel, where it files most

How often FDA has decided Intelligent Surgical Lasers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intelligent Surgical Lasers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intelligent Surgical Lasers, Inc. 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?

  • LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla1decision
  • GEXPowered Laser Surgical Instrument1decision

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.

  • K892058ISL QC 2000Intelligent Surgical Lasers, Inc. · 19892cite it

What has FDA decided for it lately?

  • K941694Isl QC 2000 LaserIntelligent Surgical Lasers, Inc. · 1994
  • K892058ISL QC 2000Intelligent Surgical Lasers, Inc. · 1989

All 2 as Intelligent Surgical Lasers, Inc. →

Other applicant names beginning “Intelligent”

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

Intelligent Hearing Systems 13Intelligent Implant Systems, LLC 6Intelligent Medical Devices, Inc. 4Intelligent Medicine, Inc. 4Intelligent Orthopaedics, Ltd. 3Intelligent Medical Systems 2Intelligent Ultrasound Limited 2Intelligent Product Limited Co. 2Intelligent Images Srl 2Intelligent Software Systems, Inc. 1Intelligent Sensory Concept SA 1Intelligent Medica Imaging, Inc. 1