Cleared Special

K192005 - Bausch + Lomb PreVue Inserter for enVis...

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

K192005 · Bausch & Lomb, Inc. · Ophthalmic device
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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.

View all Bausch & Lomb, Inc. devices

Submission Details

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.

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 15
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K192005.
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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