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FDA 510(k)

IOL INJECTOR SET

K-Number: K070669 · 2007-11-01

ApplicantMedicel AG
Decision Date2007-11-01
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IOL INJECTOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Medicel AG. It received FDA 510(k) clearance on 2007-11-01 under 510(k) number K070669. 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 IOL INJECTOR SET?

IOL INJECTOR SET is a medical device that received FDA 510(k) clearance on 2007-11-01. The listed applicant is Medicel AG. The 510(k) number is K070669.

When did IOL INJECTOR SET receive FDA 510(k) clearance?

IOL INJECTOR SET received FDA 510(k) clearance on 2007-11-01, under 510(k) number K070669.

Who is the listed applicant for IOL INJECTOR SET?

The FDA 510(k) record lists Medicel AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IOL INJECTOR SET?

The FDA product code for IOL INJECTOR SET is KYB.

Related Clinical Trials

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.

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Other records listing Medicel AG 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.

K252540ACCUJECT Injector Set 2.1-1P (LP604590)K231106Accuject Refra Injector AR2900K101134VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430K092023NAVIJECT SUB2-1P, MODEL: LP604430K040837MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

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.K063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.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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