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FDA 510(k)

THE LENS OR OMMI-GARD

K-Number: K800521 · 1980-03-12

ApplicantGentex Corporation
Decision Date1980-03-12
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THE LENS OR OMMI-GARD is the device name listed in this FDA 510(k) record. The listed applicant is Gentex Corporation. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800521. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE LENS OR OMMI-GARD?

THE LENS OR OMMI-GARD is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Gentex Corporation. The 510(k) number is K800521.

When did THE LENS OR OMMI-GARD receive FDA 510(k) clearance?

THE LENS OR OMMI-GARD received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800521.

Who is the listed applicant for THE LENS OR OMMI-GARD?

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

What is the FDA product code for THE LENS OR OMMI-GARD?

The FDA product code for THE LENS OR OMMI-GARD is HQG.

Other records listing Gentex Corporation 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.

K080117PATIENT ISOLATION UNIT, MODEL G019-1000K772024RX LENS SERIES

Related Devices (Code: HQG)

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.

K935919SUNGLASSESJa-Ru, Inc.K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXOptical Radiation Corp.K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOROnufryk Low Vision Ent.K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSESSeiko Corp.K882814NEOLENS PRESCRIPTION SPECTACLE LENSNeolens, Inc.K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens System

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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