Cleared Special

K132593 - CRYSTALSERT DELIVERY SYSTEM

K132593 is an FDA 510(k) clearance for CRYSTALSERT DELIVERY SYSTEM, 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 29-day FDA review.

K132593 · Bausch & Lomb · Ophthalmic device
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Sep 2013
Decision
29d
Days
Class 1
Risk

K132593 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 September 17, 2013 after a review of 29 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 devices

FDA 510(k) Submission Details - K132593

510(k) Number K132593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2013
Decision Date September 17, 2013
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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 42
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K132593.
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EASY-LOAD LENS DELIVERY SYSTEM
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K122848 · Lenstec, Inc. · Oct 2013
CRYSTALSERT DELIVERY SYSTEM
K123736 · Bausch & Lomb · May 2013
Z CARTRIDGE IOL DELIVERY SYSTEM
K123888 · Aaren Scientific, Inc. · Apr 2013
BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012