Cleared Special

K133146 - BAUSCH + LUMB, VIS100 INJECTOR SYSTEM

K133146 is an FDA 510(k) clearance for BAUSCH + LUMB, manufactured by Bausch & Lomb. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Special 510(k) pathway after a 78-day FDA review.

K133146 · Bausch & Lomb · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
78d
Days
Class 1
Risk

K133146 is an FDA 510(k) clearance for the BAUSCH + LUMB, VIS100 INJECTOR SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch & Lomb (Irvine, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 78 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133146

510(k) Number K133146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date January 03, 2014
Days to Decision 78 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 110d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

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 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K133146.
RAYSERT PLUS INJECTOR
K141091 · Rayner Intraocular Lenses , Ltd. · May 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
K132002 · Rayner Intraocular Lenses , Ltd. · Mar 2014
BAUSCH & LOMB INJECTOR SYSTEM
K131958 · Bausch & Lomb · Jan 2014
EASY-LOAD LENS DELIVERY SYSTEM
K132481 · Bausch & Lomb · Dec 2013
LENSTEC LC INJECTION SYSTEM
K122848 · Lenstec, Inc. · Oct 2013
CRYSTALSERT DELIVERY SYSTEM
K132593 · Bausch & Lomb · Sep 2013
K133146 · BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
Download PDF FDA Summary Bausch & Lomb