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FDA 510(k)

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28

K-Number: K063694 · 2007-03-07

ApplicantBausch & Lomb, Inc.
Decision Date2007-03-07
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2007-03-07 under 510(k) number K063694. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28?

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K063694.

When did AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 receive FDA 510(k) clearance?

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 received FDA 510(k) clearance on 2007-03-07, under 510(k) number K063694.

Who is the listed applicant for AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28?

The FDA 510(k) record lists Bausch & Lomb, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28?

The FDA product code for AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 is KYB.

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Other records listing Bausch & Lomb, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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Related Devices (Code: KYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.K022723MASTEL 1 FOLDER IMPLANTATION SYSTEMMastel Precision, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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