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FDA 510(k)

GLISLENS

K-Number: K823528 · 1982-12-22

ApplicantBio-Products, Inc.
Decision Date1982-12-22
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

GLISLENS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Products, Inc.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823528. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLISLENS?

GLISLENS is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Bio-Products, Inc.. The 510(k) number is K823528.

When did GLISLENS receive FDA 510(k) clearance?

GLISLENS received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823528.

Who is the listed applicant for GLISLENS?

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

What is the FDA product code for GLISLENS?

The FDA product code for GLISLENS is HPX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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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