Cleared Traditional

K060533 - LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM

K060533 is an FDA 510(k) clearance for LENSTEC INTRAOCULAR LENS (IOL) INJECTIO..., manufactured by Lenstec, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K060533 · Lenstec, Inc. · Ophthalmic device
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Apr 2006
Decision
45d
Days
Class 1
Risk

K060533 is an FDA 510(k) clearance for the LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Lenstec, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on April 14, 2006 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lenstec, Inc. devices

FDA 510(k) Submission Details - K060533

510(k) Number K060533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2006
Decision Date April 14, 2006
Days to Decision 45 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
65d faster than avg
Panel avg: 110d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 43
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K060533.
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