510(k) Report

FDA applicant

Sie Ag,Surgical Instument Engineering

Greenwood Village, CO1 decision2012–20121 recall

FDA records 1 decision for Sie Ag,Surgical Instument Engineering (Greenwood Village, CO) in 2012: 1 510(k) clearance. All are in product code HQF (Laser, Ophthalmic). 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, ophthalmic panel, where it files most

How often FDA has decided Sie Ag,Surgical Instument Engineering’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2012high 1 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Sie Ag,Surgical Instument Engineering by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQFLaser, Ophthalmic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K112154Femto LDVSie Ag,Surgical Instument Engineering · 20121cites it

What has FDA decided for it lately?

  • K112154Femto LDVSie Ag,Surgical Instument Engineering · 20121 recall

The one decision as Sie Ag,Surgical Instument Engineering →

What has been recalled?

1 recall linked to its devices; the latest:

  • K1121541) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated…Apr 16, 2013Class II