510(k) Report

FDA applicant

Hgm Medical Laser Systems, Inc.

Salt Lake City, UT18 decisions1988–19921 recall

FDA records 18 decisions for Hgm Medical Laser Systems, Inc. (Salt Lake City, UT) from 1988 to 1992: 18 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FEX (Instrument, Catheter, Punch). 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 Hgm Medical Laser Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hgm Medical Laser Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hgm Medical Laser Systems, 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 Instrument12decisions
  • FEXInstrument, Catheter, Punch1decision
  • HQFLaser, Ophthalmic1decision
  • HETLaparoscope, Gynecologic (And Accessories)1decision
  • HHRLaser, Surgical, Gynecologic1decision
  • HLIOphthalmoscope, Ac-Powered1decision

Also: HGF (1).

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.

  • K913569Compac a, Elite a, Elite a Plus, Surgica aHgm Medical Laser Systems, Inc. · 19912cite it

What has FDA decided for it lately?

  • K921300Model PC Argon Ion LaserHgm Medical Laser Systems, Inc. · 1992
  • K914484Litespot (TM) Laser Indirect OphthalmoscopeHgm Medical Laser Systems, Inc. · 1992
  • K913569Compac a, Elite a, Elite a Plus, Surgica aHgm Medical Laser Systems, Inc. · 19911 recall
  • K912628Air Argon Ion Lasers Various ModelsHgm Medical Laser Systems, Inc. · 1991
  • K910272HGM Combination ND:Yag & Solid State GreenHgm Medical Laser Systems, Inc. · 1991
  • K912438Models 5,8,20,20S Argon Ion LasersHgm Medical Laser Systems, Inc. · 1991
  • K910602HGM Argon Ion & Solid Light Laser for DentistryHgm Medical Laser Systems, Inc. · 1991
  • K911104Photcoagulator KR-568 Laser Spectrum Elite K1Hgm Medical Laser Systems, Inc. · 1991

All 18 as Hgm Medical Laser Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K913569Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before…Feb 1, 2006