510(k) Report

FDA applicant

Lasering S.R.L.

San Ramon, CA3 decisions2007–20110 recalls

FDA records 3 decisions for Lasering S.R.L. (San Ramon, CA) from 2007 to 2011: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 11 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 Lasering S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 22011: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lasering S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lasering S.R.L.’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
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 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.

  • K063001Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 20077cite it
  • K110984Slim E30 II CO2 LaserLasering S.R.L. · 20112cite it
  • K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 20072cite it

What has FDA decided for it lately?

  • K110984Slim E30 II CO2 LaserLasering S.R.L. · 2011
  • K063001Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
  • K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007

All 3 as Lasering S.R.L. →