Cleared Traditional

K123736 - CRYSTALSERT DELIVERY SYSTEM

K123736 is the FDA 510(k) clearance for CRYSTALSERT DELIVERY SYSTEM by Bausch & Lomb. It is a Class 1 Ophthalmic device (product code MSS) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K123736 · Bausch & Lomb · Ophthalmic device
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May 2013
Decision
162d
Days
Class 1
Risk

K123736 is an FDA 510(k) clearance for the CRYSTALSERT DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch & Lomb (Alusi Vuejo, US). The FDA issued a Cleared decision on May 16, 2013 after a review of 162 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K123736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2012
Decision Date May 16, 2013
Days to Decision 162 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 110d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

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 16
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K123736.
RxSight Insertion Device
K181401 · Rxsight, Inc. · Jul 2018
Crystalsert Lens Delivery System
K173480 · Bausch & Lomb, Inc. · Dec 2017
Bausch + Lomb Injector System
K151102 · Bausch & Lomb, Inc. · May 2015
BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008