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FDA 510(k)

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES

K-Number: K050638 · 2005-05-31

ApplicantLenstec, Inc.
Decision Date2005-05-31
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Lenstec, Inc.. It received FDA 510(k) clearance on 2005-05-31 under 510(k) number K050638. 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 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES?

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES is a medical device that received FDA 510(k) clearance on 2005-05-31. The listed applicant is Lenstec, Inc.. The 510(k) number is K050638.

When did LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES receive FDA 510(k) clearance?

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES received FDA 510(k) clearance on 2005-05-31, under 510(k) number K050638.

Who is the listed applicant for LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES?

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

What is the FDA product code for LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES?

The FDA product code for LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES is MSS.

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 Lenstec, Inc. 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.

K161776Lenstec LC Injection systemK122848LENSTEC LC INJECTION SYSTEMK091915FLUID ISOLATION DEVICEK063802LENSTEC LC INJECTION SYSTEMK060533LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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