Cleared Traditional

K090633 - LENSAR LASER SYSTEM

K090633 is an FDA 510(k) clearance for LENSAR LASER SYSTEM, manufactured by Lensar, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K090633 · Lensar, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
430d
Days
Class 2
Risk

K090633 is an FDA 510(k) clearance for the LENSAR LASER SYSTEM. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Lensar, Inc. (Winter Park, US). The FDA issued a Cleared decision on May 13, 2010 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Lensar, Inc. devices

FDA 510(k) Submission Details - K090633

510(k) Number K090633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date May 13, 2010
Days to Decision 430 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
320d slower than avg
Panel avg: 110d · This submission: 430d
Pathway characteristics
Predicate-based equivalence.

OOE Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01001117 Unknown Interventional Industry-sponsored

Laser Treatment of the Crystalline Lens

A Prospective Single-Center Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens in Subjects Having Elected to Undergo Lens Extraction and Intraocular Lens Implantation

75
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Cataract
Study design Single group
Eligibility All sexes
Principal investigator Ramon Naranjo, MD
Sponsor LensAR Incorporated (industry)
Started 2008-10-01 → Primary completion 2009-10-01 → Completed 2011-04-01
Primary outcome
Capsulotomy a. Ease of opening b. Achievement of intended shape and size
View full study on ClinicalTrials.gov

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 K090633.
TBD
K112098 · Lensar, Inc. · Oct 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · Lensar, Inc. · Mar 2011
LENSX LASER SYSTEM
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LENSX 550 LASER SYSTEM. MODEL 550
K094052 · Lensx Lasers, Inc. · Apr 2010
LENSX 550 LASER SYSTEM
K092647 · Lensx Lasers, Inc. · Dec 2009
LENSX 550 LASER SYSTEM
K082947 · Lensx Lasers, Inc. · Aug 2009