Cleared Traditional

CATALYS Precision Laser system

K220516 · Amo Manufacturing USA, LLC · Ophthalmic

May 2022

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K220516 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 May 17, 2022, 83 days after receiving the submission on February 23, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K220516 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2022
Decision Date	May 17, 2022
Days to Decision	83 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.