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FDA 510(k)

UVASORB-400

K-Number: K854442 · 1986-02-19

ApplicantOptatint, Inc.
Decision Date1986-02-19
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

UVASORB-400 is the device name listed in this FDA 510(k) record. The listed applicant is Optatint, Inc.. It received FDA 510(k) clearance on 1986-02-19 under 510(k) number K854442. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UVASORB-400?

UVASORB-400 is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Optatint, Inc.. The 510(k) number is K854442.

When did UVASORB-400 receive FDA 510(k) clearance?

UVASORB-400 received FDA 510(k) clearance on 1986-02-19, under 510(k) number K854442.

Who is the listed applicant for UVASORB-400?

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

What is the FDA product code for UVASORB-400?

The FDA product code for UVASORB-400 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

Other records listing Optatint, Inc. 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.

K850909RHODA-LUX LENS BLANKS

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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