FEMTO LDV Z8 Surgical Laser— 510(k) K150323
Substantially EquivalentSie Ag,Surgical Instrument Engineering
FDA 510(k) clearance K150323 for FEMTO LDV Z8 Surgical Laser, Substantially Equivalent on 2015-10-23. Applicant: Sie Ag,Surgical Instrument Engineering. Device class: 2.
Clearance details
- Applicant
- Sie Ag,Surgical Instrument Engineering
- Product code
- Code OOE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Port, CH
Recent devices under product code OOE
view allMore clearances from Sie Ag,Surgical Instrument Engineering
view allAdverse events under product code OOE
product code OOE- Injury
- 1,104
- Malfunction
- 864
- Total
- 1,968
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 K150323
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 K150323.
Data sourced from openFDA. This site is unofficial and independent of the FDA.