Cleared Traditional

K182083 - Catalys Precision Laser System (FDA 510(k) Clearance)

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

K182083 · Amo Manufacturing USA, LLC · Ophthalmic device
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Nov 2018
Decision
99d
Days
Class 2
Risk

K182083 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 Manufacturing USA, LLC (Milpitas, US). The FDA issued a Cleared decision on November 9, 2018 after a review of 99 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 Manufacturing USA, LLC devices

Submission Details

510(k) Number K182083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2018
Decision Date November 09, 2018
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
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 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K182083.
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