FEMTO LDV— 510(k) K112154
Substantially EquivalentSie Ag,Surgical Instument Engineering
FDA 510(k) clearance K112154 for FEMTO LDV, Substantially Equivalent on 2012-03-16. Applicant: Sie Ag,Surgical Instument Engineering. Device class: 2.
Clearance details
- Applicant
- Sie Ag,Surgical Instument Engineering
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwood Village, CO, US
Recent devices under product code HQF
view allAdverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112154
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112154.
Data sourced from openFDA. This site is unofficial and independent of the FDA.