FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER— 510(k) K131207

Substantially Equivalent

Surgical Instrument Engineering AG

FDA 510(k) clearance K131207 for FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER, Substantially Equivalent on 2013-10-09. Applicant: Surgical Instrument Engineering AG.

Clearance details

Applicant: Surgical Instrument Engineering AG
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2013-04-29
Decision date: 2013-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, 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.