Cleared Traditional

FEMTO LDV Z8 Femtosecond Surgical Laser

K213559 · Sie Ag,Surgical Instrument Engineering · Ophthalmic

Apr 2022

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K213559 is an FDA 510(k) clearance for the FEMTO LDV Z8 Femtosecond Surgical Laser, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Sie Ag,Surgical Instrument Engineering (Port, CH). The FDA issued a Cleared decision on April 21, 2022, 168 days after receiving the submission on November 4, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K213559 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2021
Decision Date	April 21, 2022
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OOE — Ophthalmic Femtosecond Laser
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4390
Definition	Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.