Cleared Traditional

K122848 - LENSTEC LC INJECTION SYSTEM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K122848 · Lenstec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 61
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K122848.
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540 · Medicel AG · Sep 2025
EyeGility™ Inserter for Preloaded enVista IOLs
K242389 · Bausch & Lomb, Incorporated · Oct 2024
Accuject Refra Injector AR2900
K231106 · Medicel AG · Sep 2023
RxSight® Insertion Device (63002)
K231838 · Rxsight, Inc. · Aug 2023
RxSight Insertion Device
K231466 · Rxsight, Inc. · Jun 2023
CLAREON MONARCH IV IOL Delivery System
K212039 · Alcon Laboratories, Inc. · Aug 2021