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FDA 510(k)

DURALITE LENS

K-Number: K800192 · 1980-03-12

ApplicantAmerican Optical Corp.
Decision Date1980-03-12
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

DURALITE LENS is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800192. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURALITE LENS?

DURALITE LENS is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is American Optical Corp.. The 510(k) number is K800192.

When did DURALITE LENS receive FDA 510(k) clearance?

DURALITE LENS received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800192.

Who is the listed applicant for DURALITE LENS?

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

What is the FDA product code for DURALITE LENS?

The FDA product code for DURALITE LENS is HPX.

Related Clinical Trials

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Other records listing American Optical Corp. 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.

K950881PHACO TIPK950880AOI UNIVERSAL ULTRASONIC HANDPIECEK931354P4000 PHACOEMULSIFIERK931358AORP4000 REUSABLE PAKK931357AOD4000 DISPOSABLE PAKK820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

View all 35 devices →

Related Devices (Code: HPX)

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.

K955777PMMA CLASICRand Scientific Corp.K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.K913081MULTI-VIEW BIFOCALSCamp Contact LensesK897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward HensleyK895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.

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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