Cleared Special

K063694 - AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28

K063694 is an FDA 510(k) clearance for AKREOS SINGLE USE INSERTION DEVICE, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Special 510(k) pathway after a 84-day FDA review.

K063694 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K063694

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

KYB Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 33
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K063694.
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
K072985 · Duckworth & Kent, Ltd. · Jun 2008
IOL INJECTOR SET
K070669 · Medicel AG · Nov 2007
MONARCH III IOL DELIVERY SYSTEM
K063155 · Alcon Manufacturing, Ltd. · Mar 2007
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · Staar Surgical Co. · Jun 2004
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K022723 · Mastel Precision, Inc. · Dec 2002
MONARCH II IOL DELIVERY SYSTEM
K001157 · Alcon Research, Ltd. · Jun 2000
K063694 · AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
Download PDF FDA Summary Bausch & Lomb, Inc.