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FDA 510(k)

LENS-EZE

K-Number: K862094 · 1986-06-19

ApplicantInsight International, Inc.
Decision Date1986-06-19
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENS-EZE is the device name listed in this FDA 510(k) record. The listed applicant is Insight International, Inc.. It received FDA 510(k) clearance on 1986-06-19 under 510(k) number K862094. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENS-EZE?

LENS-EZE is a medical device that received FDA 510(k) clearance on 1986-06-19. The listed applicant is Insight International, Inc.. The 510(k) number is K862094.

When did LENS-EZE receive FDA 510(k) clearance?

LENS-EZE received FDA 510(k) clearance on 1986-06-19, under 510(k) number K862094.

Who is the listed applicant for LENS-EZE?

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

What is the FDA product code for LENS-EZE?

The FDA product code for LENS-EZE is HJK.

Other records listing Insight International, 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.

K910816IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE

Related Devices (Code: HJK)

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.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

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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