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FDA 510(k)

RX LENS SERIES

K-Number: K772024 · 1977-11-09

ApplicantGentex Corporation
Decision Date1977-11-09
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RX LENS SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Gentex Corporation. It received FDA 510(k) clearance on 1977-11-09 under 510(k) number K772024. 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 RX LENS SERIES?

RX LENS SERIES is a medical device that received FDA 510(k) clearance on 1977-11-09. The listed applicant is Gentex Corporation. The 510(k) number is K772024.

When did RX LENS SERIES receive FDA 510(k) clearance?

RX LENS SERIES received FDA 510(k) clearance on 1977-11-09, under 510(k) number K772024.

Who is the listed applicant for RX LENS SERIES?

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 RX LENS SERIES?

The FDA product code for RX LENS SERIES is HQG.

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 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 G019-1000K800521THE LENS OR OMMI-GARD

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

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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