Cleared Special

CATALYS Precision Laser System

K210701 · Amo Manufacturing USA, LLC · Ophthalmic

Apr 2021

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K210701 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 April 7, 2021, 29 days after receiving the submission on March 9, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K210701 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2021
Decision Date	April 07, 2021
Days to Decision	29 days
Submission Type	Special
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.