Cleared Special

K161012 - Easy-Load Lens Delivery System

K161012 is an FDA 510(k) clearance for Easy-Load Lens Delivery System, manufactured by Bausch and Lomb, Inc.,. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Special 510(k) pathway after a 86-day FDA review.

K161012 · Bausch and Lomb, Inc., · Ophthalmic device
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Jul 2016
Decision
86d
Days
Class 1
Risk

K161012 is an FDA 510(k) clearance for the Easy-Load Lens Delivery System. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch and Lomb, Inc., (Irvine, US). The FDA issued a Cleared decision on July 6, 2016 after a review of 86 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 and Lomb, Inc., devices

FDA 510(k) Submission Details - K161012

510(k) Number K161012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2016
Decision Date July 06, 2016
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 K161012.
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