510(k) Report

FDA applicant

Aesthera Corporation

Concord, CA3 decisions2005–20090 recalls

FDA records 3 decisions for Aesthera Corporation (Concord, CA) from 2005 to 2009: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 17 predicates, 2 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 Aesthera Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aesthera Corporation 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?

  • GEXPowered Laser Surgical Instrument3decisions

Whose devices does it build on?

Its devices cite 17 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K083730IsolazAesthera Corporation · 20092cite it
  • K041554Aip Intense Pulsed Light SystemAesthera Corporation · 20052cite it
  • K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 20061cites it

What has FDA decided for it lately?

  • K083730IsolazAesthera Corporation · 2009
  • K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
  • K041554Aip Intense Pulsed Light SystemAesthera Corporation · 2005

All 3 as Aesthera Corporation →