510(k) Report

FDA applicant

Medical Laser Solutions

Boston, MA4 decisions1997–20000 recalls

FDA records 4 decisions for Medical Laser Solutions (Boston, MA) from 1997 to 2000: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medical Laser Solutions, LLC”.

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 Medical Laser Solutions’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Laser Solutions since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Laser Solutions’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 Instrument4decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K962902Fotona Skinlight Laser SystemMedical Laser Solutions · 19974cite it
  • K970757Fotona SkinscanMedical Laser Solutions · 19971cites it

What has FDA decided for it lately?

  • K000693Umeco Optima Multiline Laser SystemMedical Laser Solutions, LLC · 2000
  • K972368Fotona Skinlight Plus ND: Yag SystemMedical Laser Solutions · 1997
  • K970757Fotona SkinscanMedical Laser Solutions · 1997
  • K962902Fotona Skinlight Laser SystemMedical Laser Solutions · 1997

All 3 as Medical Laser Solutions →The one decision as Medical Laser Solutions, LLC →