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FDA 510(k)

SUPER VIEW DISPOSABLE BIOM LENS SET

K-Number: K051630 · 2005-06-29

ApplicantInsight Instruments, Inc.
Decision Date2005-06-29
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUPER VIEW DISPOSABLE BIOM LENS SET is the device name listed in this FDA 510(k) record. The listed applicant is Insight Instruments, Inc.. It received FDA 510(k) clearance on 2005-06-29 under 510(k) number K051630. 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 SUPER VIEW DISPOSABLE BIOM LENS SET?

SUPER VIEW DISPOSABLE BIOM LENS SET is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Insight Instruments, Inc.. The 510(k) number is K051630.

When did SUPER VIEW DISPOSABLE BIOM LENS SET receive FDA 510(k) clearance?

SUPER VIEW DISPOSABLE BIOM LENS SET received FDA 510(k) clearance on 2005-06-29, under 510(k) number K051630.

Who is the listed applicant for SUPER VIEW DISPOSABLE BIOM LENS SET?

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

What is the FDA product code for SUPER VIEW DISPOSABLE BIOM LENS SET?

The FDA product code for SUPER VIEW DISPOSABLE BIOM LENS SET is HJK.

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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 RingPhakosK051103HAAG-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.)K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESFci Ophthalmics, 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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