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FDA 510(k)

CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS

K-Number: K080632 · 2008-10-15

ApplicantClearlab SG Pte, Ltd.
Decision Date2008-10-15
Product CodeMVN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Clearlab SG Pte, Ltd.. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K080632. The device is classified under product code MVN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS?

CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Clearlab SG Pte, Ltd.. The 510(k) number is K080632.

When did CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS receive FDA 510(k) clearance?

CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS received FDA 510(k) clearance on 2008-10-15, under 510(k) number K080632.

Who is the listed applicant for CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS?

The FDA 510(k) record lists Clearlab SG Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS?

The FDA product code for CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS is MVN.

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 Clearlab SG Pte, Ltd. 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.

K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

Related Devices (Code: MVN)

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.

K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact LensHOYA Lamphun , Ltd.K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.K130331SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERSauflon Pharmaceuticals, Ltd.K112192NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENSBausch & Lomb, Inc.K080755SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENSBausch & Lomb, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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