FEMTO LDV— 510(k) K112154

Substantially Equivalent

Sie Ag,Surgical Instument Engineering

FDA 510(k) clearance K112154 for FEMTO LDV, Substantially Equivalent on 2012-03-16. Applicant: Sie Ag,Surgical Instument Engineering.

Clearance details

Applicant: Sie Ag,Surgical Instument Engineering
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2011-07-27
Decision date: 2012-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.