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FDA 510(k)

ELASTIC LENS INJECTOR TM

K-Number: K861085 · 1986-05-28

ApplicantStaar Surgical Co.
Decision Date1986-05-28
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ELASTIC LENS INJECTOR TM is the device name listed in this FDA 510(k) record. The listed applicant is Staar Surgical Co.. It received FDA 510(k) clearance on 1986-05-28 under 510(k) number K861085. 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 ELASTIC LENS INJECTOR TM?

ELASTIC LENS INJECTOR TM is a medical device that received FDA 510(k) clearance on 1986-05-28. The listed applicant is Staar Surgical Co.. The 510(k) number is K861085.

When did ELASTIC LENS INJECTOR TM receive FDA 510(k) clearance?

ELASTIC LENS INJECTOR TM received FDA 510(k) clearance on 1986-05-28, under 510(k) number K861085.

Who is the listed applicant for ELASTIC LENS INJECTOR TM?

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

What is the FDA product code for ELASTIC LENS INJECTOR TM?

The FDA product code for ELASTIC LENS INJECTOR TM is KYB.

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Other records listing Staar Surgical Co. 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.

K090161EPIPHANY INJECTION SYSTEMK073586MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEMK073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEMK032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SK020734SURGE-FREE ASPIRATION ADAPTERK983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)

View all 22 devices →

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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