Cleared Traditional

Catalys Precision Laser System

K172002 · Amo Manufacturing USA, LLC · Ophthalmic

Aug 2017

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K172002 is an FDA 510(k) clearance for the Catalys Precision Laser System, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Amo Manufacturing USA, LLC (Milpitas, US). The FDA issued a Cleared decision on August 25, 2017, 53 days after receiving the submission on July 3, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K172002 FDA.gov
FDA Decision	Cleared 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

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.