Cleared Traditional

ELITA? Femtosecond Laser System, ELITA? Patient Interface

K223566 · Johnson & Johnson Surgical Vision, Inc. · Ophthalmic

Apr 2023

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K223566 is an FDA 510(k) clearance for the ELITA? Femtosecond Laser System, ELITA? Patient Interface, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Johnson & Johnson Surgical Vision, Inc. (Irvine, US). The FDA issued a Cleared decision on April 14, 2023, 136 days after receiving the submission on November 29, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K223566 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2022
Decision Date	April 14, 2023
Days to Decision	136 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.