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FDA 510(k)

VARILUX VISIONPRINT SYSTEM (VPS)

K-Number: K033949 · 2004-07-02

ApplicantEssilor Intl.
Decision Date2004-07-02
Product CodeHLL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VARILUX VISIONPRINT SYSTEM (VPS) is the device name listed in this FDA 510(k) record. The listed applicant is Essilor Intl.. It received FDA 510(k) clearance on 2004-07-02 under 510(k) number K033949. The device is classified under product code HLL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARILUX VISIONPRINT SYSTEM (VPS)?

VARILUX VISIONPRINT SYSTEM (VPS) is a medical device that received FDA 510(k) clearance on 2004-07-02. The listed applicant is Essilor Intl.. The 510(k) number is K033949.

When did VARILUX VISIONPRINT SYSTEM (VPS) receive FDA 510(k) clearance?

VARILUX VISIONPRINT SYSTEM (VPS) received FDA 510(k) clearance on 2004-07-02, under 510(k) number K033949.

Who is the listed applicant for VARILUX VISIONPRINT SYSTEM (VPS)?

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

What is the FDA product code for VARILUX VISIONPRINT SYSTEM (VPS)?

The FDA product code for VARILUX VISIONPRINT SYSTEM (VPS) is HLL.

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 Essilor Intl. 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.

K003170RYTHMIC AND RYTHMIC UV

Related Devices (Code: HLL)

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.

K222484RetitrackC. Light Technologies, Inc.K152890SACCADOMETER PLUS, SACCADOMETER ADVANCEDOber Consulting Sp. Z.O.O.K872111ORTHOTONEOrthotone Corp.

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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