Cleared Traditional

K213559 - FEMTO LDV Z8 Femtosecond Surgical Laser (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213559 · Sie Ag,Surgical Instrument Engineering · Ophthalmic device
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Apr 2022
Decision
168d
Days
Class 2
Risk

K213559 is an FDA 510(k) clearance for the FEMTO LDV Z8 Femtosecond Surgical Laser. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Sie Ag,Surgical Instrument Engineering (Port, CH). The FDA issued a Cleared decision on April 21, 2022 after a review of 168 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sie Ag,Surgical Instrument Engineering devices

Submission Details

510(k) Number K213559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 110d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOE Ophthalmic Femtosecond Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
Definition Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OOE Ophthalmic Femtosecond Laser

All 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K213559.
LenSx Laser System (8065000944)
K252682 · Alcon Laboratories, Inc. · Sep 2025
LenSx Laser System (8065998162)
K243896 · Alcon Laboratories, Inc. · Apr 2025
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
K223566 · Johnson & Johnson Surgical Vision, Inc. · Apr 2023
Catalys™ Precision Laser System
K223838 · Amo Manufacturing USA, LLC · Apr 2023
ALLY Adaptive Cataract Treatment System
K220259 · Lensar, Inc. · Jun 2022
CATALYS Precision Laser system
K220516 · Amo Manufacturing USA, LLC · May 2022