Cleared Traditional

K223566 - ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223566 · Johnson & Johnson Surgical Vision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
136d
Days
Class 2
Risk

K223566 is an FDA 510(k) clearance for the ELITA™ Femtosecond Laser System, ELITA™ Patient Interface. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Johnson & Johnson Surgical Vision, Inc. (Irvine, US). The FDA issued a Cleared decision on April 14, 2023 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson & Johnson Surgical Vision, Inc. devices

Submission Details

510(k) Number K223566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 110d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOE Ophthalmic Femtosecond Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
Definition Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OOE Ophthalmic Femtosecond Laser

All 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K223566.
LenSx Laser System (8065000944)
K252682 · Alcon Laboratories, Inc. · Sep 2025
LenSx Laser System (8065998162)
K243896 · Alcon Laboratories, Inc. · Apr 2025
Catalys™ Precision Laser System
K223838 · Amo Manufacturing USA, LLC · Apr 2023
ALLY Adaptive Cataract Treatment System
K220259 · Lensar, Inc. · Jun 2022
CATALYS Precision Laser system
K220516 · Amo Manufacturing USA, LLC · May 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · Sie Ag,Surgical Instrument Engineering · Apr 2022