Cleared Traditional

K220516 - CATALYS Precision Laser system (FDA 510(k) Clearance)

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

K220516 · Amo Manufacturing USA, LLC · Ophthalmic device
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May 2022
Decision
83d
Days
Class 2
Risk

K220516 is an FDA 510(k) clearance for the CATALYS Precision Laser system. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Amo Manufacturing USA, LLC (Milpitas, US). The FDA issued a Cleared decision on May 17, 2022 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amo Manufacturing USA, LLC devices

Submission Details

510(k) Number K220516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
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 K220516.
LenSx Laser System (8065000944)
K252682 · Alcon Laboratories, Inc. · Sep 2025
LenSx Laser System (8065998162)
K243896 · Alcon Laboratories, Inc. · Apr 2025
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
K223566 · Johnson & Johnson Surgical Vision, Inc. · Apr 2023
Catalys™ Precision Laser System
K223838 · Amo Manufacturing USA, LLC · Apr 2023
ALLY Adaptive Cataract Treatment System
K220259 · Lensar, Inc. · Jun 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · Sie Ag,Surgical Instrument Engineering · Apr 2022