Cleared Traditional

K063802 - LENSTEC LC INJECTION SYSTEM

K063802 is an FDA 510(k) clearance for LENSTEC LC INJECTION SYSTEM, 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 136-day FDA review.

K063802 · Lenstec, Inc. · Ophthalmic device
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May 2007
Decision
136d
Days
Class 1
Risk

K063802 is an FDA 510(k) clearance for the LENSTEC LC 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 May 7, 2007 after a review of 136 days - within the typical 510(k) review window.

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: 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 Lenstec, Inc. devices

FDA 510(k) Submission Details - K063802

510(k) Number K063802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date May 07, 2007
Days to Decision 136 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
26d slower than avg
Panel avg: 110d · This submission: 136d
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 K063802.
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LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
K050638 · Lenstec, Inc. · May 2005
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001
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K002556 · Pharmacia & Upjohn Co. · Oct 2000