Cleared Traditional

K172002 - Catalys Precision Laser System

K172002 is an FDA 510(k) clearance for Catalys Precision Laser System, manufactured by Amo Manufacturing USA, LLC. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K172002 · Amo Manufacturing USA, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
53d
Days
Class 2
Risk

K172002 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 August 25, 2017 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amo Manufacturing USA, LLC devices

FDA 510(k) Submission Details - K172002

510(k) Number K172002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date August 25, 2017
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OOE Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K172002.
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · Lensar, Inc. · Aug 2018
LenSx Laser System
K173660 · Alcon Laboratories, Inc. · Mar 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346 · Lensar, Inc. · Mar 2018
LenSx Laser System
K163551 · Alcon Laboratories, Inc. · Feb 2017
LenSX Laser System
K161288 · Alcon Laboratories, Inc. · Nov 2016