Cleared Traditional

K082947 - LENSX 550 LASER SYSTEM

K082947 is an FDA 510(k) clearance for LENSX 550 LASER SYSTEM, 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 316-day FDA review.

K082947 · Lensx Lasers, Inc. · Ophthalmic device
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Aug 2009
Decision
316d
Days
Class 2
Risk

K082947 is an FDA 510(k) clearance for the LENSX 550 LASER SYSTEM. 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 August 14, 2009 after a review of 316 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K082947

510(k) Number K082947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2008
Decision Date August 14, 2009
Days to Decision 316 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
206d slower than avg
Panel avg: 110d · This submission: 316d
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.