FEMTO LDV Z8 Femtosecond Surgical Laser— 510(k) K213559

Substantially Equivalent

Sie Ag,Surgical Instrument Engineering

FDA 510(k) clearance K213559 for FEMTO LDV Z8 Femtosecond Surgical Laser, Substantially Equivalent on 2022-04-21. Applicant: Sie Ag,Surgical Instrument Engineering.

Clearance details

Applicant: Sie Ag,Surgical Instrument Engineering
Product code: Code OOE
Advisory panel: Ophthalmic
Date received: 2021-11-04
Decision date: 2022-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOE

product code OOE

Injury: 1,104
Malfunction: 864
Total: 1,968

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.