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FDA 510(k)

INTRAOCULAR LENS GUIDE

K-Number: K823222 · 1982-12-28

ApplicantAmerican Medical Optics
Decision Date1982-12-28
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTRAOCULAR LENS GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Optics. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823222. 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 INTRAOCULAR LENS GUIDE?

INTRAOCULAR LENS GUIDE is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is American Medical Optics. The 510(k) number is K823222.

When did INTRAOCULAR LENS GUIDE receive FDA 510(k) clearance?

INTRAOCULAR LENS GUIDE received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823222.

Who is the listed applicant for INTRAOCULAR LENS GUIDE?

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

What is the FDA product code for INTRAOCULAR LENS GUIDE?

The FDA product code for INTRAOCULAR LENS GUIDE is KYB.

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Other records listing American Medical Optics 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.

K860001BARRAQUER-KRUMEICH REFRACTIVE SETK851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOPK851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMASK851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMAK844150MEDICAL OPTICS PHACOEMULSIFICATION KITK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

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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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