Cleared Traditional

K094052 - LENSX 550 LASER SYSTEM. MODEL 550

K094052 is an FDA 510(k) clearance for LENSX 550 LASER SYSTEM. MODEL 550, manufactured by Lensx Lasers, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K094052 · Lensx Lasers, Inc. · Ophthalmic device
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Apr 2010
Decision
113d
Days
Class 2
Risk

K094052 is an FDA 510(k) clearance for the LENSX 550 LASER SYSTEM. MODEL 550. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Lensx Lasers, Inc. (Laguna Beach, US). The FDA issued a Cleared decision on April 23, 2010 after a review of 113 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 Lensx Lasers, Inc. devices

FDA 510(k) Submission Details - K094052

510(k) Number K094052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2009
Decision Date April 23, 2010
Days to Decision 113 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
3d slower than avg
Panel avg: 110d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.