Cleared Traditional

ALLY Adaptive Cataract Treatment System

K220259 · Lensar, Inc. · Ophthalmic

Jun 2022

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K220259 is an FDA 510(k) clearance for the ALLY Adaptive Cataract Treatment System, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on June 9, 2022, 129 days after receiving the submission on January 31, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K220259 FDA.gov
FDA Decision	Cleared 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

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.