Cleared Special

K192005 - Bausch + Lomb PreVue Inserter for enVista Preloaded

K192005 is an FDA 510(k) clearance for Bausch + Lomb PreVue Inserter for enVis..., manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Special 510(k) pathway after a 67-day FDA review.

K192005 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
67d
Days
Class 1
Risk

K192005 is an FDA 510(k) clearance for the Bausch + Lomb PreVue Inserter for enVista Preloaded. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 4, 2019 after a review of 67 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 - K192005

510(k) Number K192005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date October 04, 2019
Days to Decision 67 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
43d faster than avg
Panel avg: 110d · This submission: 67d
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 K192005.
CLAREON MONARCH IV IOL Delivery System
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K200057 · Ast Products, Inc. · Jun 2020
RxSight Insertion Device
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UNFOLDER Vitan Inserter
K191949 · Johnson & Johnson Surgical Vision, Inc. · Sep 2019
BL-Cart IOL Delivery Cartridge
K182965 · Ast Products, Inc. · Mar 2019
RxSight Insertion Device
K181401 · Rxsight, Inc. · Jul 2018
K192005 · Bausch + Lomb PreVue Inserter for enVista Preloaded
Download PDF FDA Summary Bausch & Lomb, Inc.