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FDA 510(k)

EPIPHANY INJECTION SYSTEM

K-Number: K090161 · 2009-06-09

ApplicantStaar Surgical Co.
Decision Date2009-06-09
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EPIPHANY INJECTION SYSTEM 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 2009-06-09 under 510(k) number K090161. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIPHANY INJECTION SYSTEM?

EPIPHANY INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-09. The listed applicant is Staar Surgical Co.. The 510(k) number is K090161.

When did EPIPHANY INJECTION SYSTEM receive FDA 510(k) clearance?

EPIPHANY INJECTION SYSTEM received FDA 510(k) clearance on 2009-06-09, under 510(k) number K090161.

Who is the listed applicant for EPIPHANY INJECTION SYSTEM?

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 EPIPHANY INJECTION SYSTEM?

The FDA product code for EPIPHANY INJECTION SYSTEM is MSS.

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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.

K073586MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEMK073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEMK032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SK020734SURGE-FREE ASPIRATION ADAPTERK983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)K980696FOAM TIP INJECTOR

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Related Devices (Code: MSS)

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.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, 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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