Cleared Traditional

K113852 - BAUSCH & LOMB IOL INJECTOR

K113852 is an FDA 510(k) clearance for BAUSCH & LOMB IOL INJECTOR, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K113852 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Sep 2012
Decision
274d
Days
Class 1
Risk

K113852 is an FDA 510(k) clearance for the BAUSCH & LOMB IOL INJECTOR. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Alusi Vuejo, US). The FDA issued a Cleared decision on September 28, 2012 after a review of 274 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, Inc. devices

FDA 510(k) Submission Details - K113852

510(k) Number K113852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2011
Decision Date September 28, 2012
Days to Decision 274 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
164d slower than avg
Panel avg: 110d · This submission: 274d
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 28
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