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

Name: FDA 510(k) clearance K131207
Creator: U.S. Food and Drug Administration
Published: 2013-10-09

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. Device class: 2.

Clearance details

Applicant: Surgical Instrument Engineering AG
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
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 ↗

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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 →

Recalls naming K131207

K-number listed on FDA's recall record

Z-0988-2015 — Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.Class II·Terminated·Ziemer Usa Inc·20141218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131207.

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