Cleared Special

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694) - FDA 510(k) Clearance

Class I Ophthalmic device.

K063694 · Bausch & Lomb, Inc. · Ophthalmic device
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Mar 2007
Decision
84d
Days
Class 1
Risk

K063694 is an FDA 510(k) clearance for the AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (San Dimas, US). The FDA issued a Cleared decision on March 7, 2007 after a review of 84 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, Inc. devices

Submission Details

510(k) Number K063694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date March 07, 2007
Days to Decision 84 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.