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FDA 510(k)

IOSERT LENS IMPLANT INSTRUMENT

K-Number: K854197 · 1986-01-22

ApplicantChiron Vision Corp.
Decision Date1986-01-22
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IOSERT LENS IMPLANT INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Vision Corp.. It received FDA 510(k) clearance on 1986-01-22 under 510(k) number K854197. 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 IOSERT LENS IMPLANT INSTRUMENT?

IOSERT LENS IMPLANT INSTRUMENT is a medical device that received FDA 510(k) clearance on 1986-01-22. The listed applicant is Chiron Vision Corp.. The 510(k) number is K854197.

When did IOSERT LENS IMPLANT INSTRUMENT receive FDA 510(k) clearance?

IOSERT LENS IMPLANT INSTRUMENT received FDA 510(k) clearance on 1986-01-22, under 510(k) number K854197.

Who is the listed applicant for IOSERT LENS IMPLANT INSTRUMENT?

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

What is the FDA product code for IOSERT LENS IMPLANT INSTRUMENT?

The FDA product code for IOSERT LENS IMPLANT INSTRUMENT is KYB.

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Other records listing Chiron Vision Corp. 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.

K970727MPORT FOLDABLE LENS PLACEMENT SYSTEMK972808HANSATOME MICROKERATOMEK960414SYNERGIST POWER PACKK944993IOLAB.SITE CD PHACOEMULSIFICATION MODULEK944995IOLAB/SITE PERISTALTIC MODULEK951292PASSPORT FOLDABLE LENS PLACEMENT SYSTEM

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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.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

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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