Cleared Abbreviated

UNFOLDER Vitan Inserter (K191949) - FDA 510(k) Clearance

Class I Ophthalmic device.

K191949 · Johnson & Johnson Surgical Vision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Sep 2019
Decision
53d
Days
Class 1
Risk

K191949 is an FDA 510(k) clearance for the UNFOLDER Vitan Inserter. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 13, 2019 after a review of 53 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Johnson & Johnson Surgical Vision, Inc. devices

Submission Details

510(k) Number K191949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2019
Decision Date September 13, 2019
Days to Decision 53 days
Submission Type Abbreviated
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
57d faster than avg
Panel avg: 110d · This submission: 53d
Pathway characteristics
Standards-based clearance path.

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 12
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K191949.
bioli lOL Delivery System
K200057 · Ast Products, Inc. · Jun 2020
RxSight Insertion Device
K192926 · Rxsight, Inc. · Jan 2020
Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005 · Bausch & Lomb, Inc. · Oct 2019
BL-Cart IOL Delivery Cartridge
K182965 · Ast Products, Inc. · Mar 2019
RxSight Insertion Device
K181401 · Rxsight, Inc. · Jul 2018
Crystalsert Lens Delivery System
K173480 · Bausch & Lomb, Inc. · Dec 2017