Cleared Traditional

Catalys Precision Laser System

K182083 · Amo Manufacturing USA, LLC · Ophthalmic

Nov 2018

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K182083 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 November 9, 2018, 99 days after receiving the submission on August 2, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K182083 FDA.gov
FDA Decision	Cleared 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

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.