Cleared Traditional

K123736 - CRYSTALSERT DELIVERY SYSTEM

K123736 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 Traditional 510(k) pathway after a 162-day FDA review.

K123736 · Bausch & Lomb · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Bausch & Lomb devices

FDA 510(k) Submission Details - K123736

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 110d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

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 K123736.
EASY-LOAD LENS DELIVERY SYSTEM
K132481 · Bausch & Lomb · Dec 2013
LENSTEC LC INJECTION SYSTEM
K122848 · Lenstec, Inc. · Oct 2013
CRYSTALSERT DELIVERY SYSTEM
K132593 · Bausch & Lomb · Sep 2013
Z CARTRIDGE IOL DELIVERY SYSTEM
K123888 · Aaren Scientific, Inc. · Apr 2013
BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
K112977 · Alcon Research, Ltd. · Mar 2012