Cleared Traditional

K122848 - LENSTEC LC INJECTION SYSTEM

K122848 is the FDA 510(k) clearance for LENSTEC LC INJECTION SYSTEM by Lenstec, Inc.. It is a Class 1 Ophthalmic device (product code MSS) cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K122848 · Lenstec, Inc. · Ophthalmic device
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Oct 2013
Decision
395d
Days
Class 1
Risk

K122848 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 October 18, 2013 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Lenstec, Inc. devices

Submission Details

510(k) Number K122848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2012
Decision Date October 18, 2013
Days to Decision 395 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 110d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

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 16
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K122848.
RxSight Insertion Device
K181401 · Rxsight, Inc. · Jul 2018
Crystalsert Lens Delivery System
K173480 · Bausch & Lomb, Inc. · Dec 2017
Bausch + Lomb Injector System
K151102 · Bausch & Lomb, Inc. · May 2015
BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008