Cleared Traditional

K220259 - ALLY Adaptive Cataract Treatment System (FDA 510(k) Clearance)

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

K220259 · Lensar, Inc. · Ophthalmic device
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Jun 2022
Decision
129d
Days
Class 2
Risk

K220259 is an FDA 510(k) clearance for the ALLY Adaptive Cataract Treatment System. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on June 9, 2022 after a review of 129 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 Lensar, Inc. devices

Submission Details

510(k) Number K220259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2022
Decision Date June 09, 2022
Days to Decision 129 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
19d slower than avg
Panel avg: 110d · This submission: 129d
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 K220259.
LenSx Laser System (8065000944)
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K223566 · Johnson & Johnson Surgical Vision, Inc. · Apr 2023
Catalys™ Precision Laser System
K223838 · Amo Manufacturing USA, LLC · Apr 2023
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