510(k) Report

FDA applicant

Amd Lasers, LLC

North Reading, MA2 decisions2009–20110 recalls

FDA records 2 decisions for Amd Lasers, LLC (North Reading, MA) from 2009 to 2011: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 6 predicates, 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 Amd Lasers, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12011: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Amd Lasers, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amd Lasers, LLC’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 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K083142Picasso Laser SystemAmd Lasers, LLC · 20093cite it
  • K102359Picasso/ Picasso Lite/ Picasso PerioAmd Lasers, LLC · 20113cite it

What has FDA decided for it lately?

  • K102359Picasso/ Picasso Lite/ Picasso PerioAmd Lasers, LLC · 2011
  • K083142Picasso Laser SystemAmd Lasers, LLC · 2009

All 2 as Amd Lasers, LLC →