Cleared Traditional

K200056 - Catalys Precision Laser System

K200056 is the FDA 510(k) clearance for Catalys Precision Laser System by Amo Manufacturng USA, LLC. It is a Class 2 Ophthalmic device (product code OOE) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K200056 · Amo Manufacturng USA, LLC · Ophthalmic device
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May 2020
Decision
126d
Days
Class 2
Risk

K200056 is an FDA 510(k) clearance for the Catalys Precision Laser System. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Amo Manufacturng USA, LLC (Milpitas, US). The FDA issued a Cleared decision on May 18, 2020 after a review of 126 days - within the typical 510(k) review window.

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 Amo Manufacturng USA, LLC devices

Submission Details

510(k) Number K200056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2020
Decision Date May 18, 2020
Days to Decision 126 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
16d slower than avg
Panel avg: 110d · This submission: 126d
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 Peers - OOE Ophthalmic Femtosecond Laser

All 16
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K200056.
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · Sie Ag,Surgical Instrument Engineering · Apr 2022
CATALYS Precision Laser System
K210701 · Amo Manufacturing USA, LLC · Apr 2021
VICTUS Femtosecond Laser Platform
K200724 · Technolas Perfect Vision GmbH · Sep 2020
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795 · Lensar, Inc. · Dec 2018
Catalys Precision Laser System
K182083 · Amo Manufacturing USA, LLC · Nov 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · Lensar, Inc. · Aug 2018