510(k) Report

FDA applicant

Sie Ag,Surgical Instrument Engineering

Port, CH2 decisions2015–20221 recall

FDA records 2 decisions for Sie Ag,Surgical Instrument Engineering (Port, CH) from 2015 to 2022: 2 510(k) clearances. All are in product code OOE (Ophthalmic Femtosecond Laser). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Instrument Engineering’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12022: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2015high 1 (2018) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Sie Ag,Surgical Instrument Engineering by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OOEOphthalmic Femtosecond Laser2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering · 20151cites it
  • K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering · 20221cites it

What has FDA decided for it lately?

  • K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering · 2022
  • K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering · 20151 recall

All 2 as Sie Ag,Surgical Instrument Engineering →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150323The FEMTO LDV (TM)Z8 Femtosecond Surgical Laser The FEMTO LDV (TM)Z8 Femtosecond…Jan 21, 2018Class II