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FDA 510(k)

PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES

K-Number: K991965 · 1999-10-01

ApplicantPurilens, Inc.
Decision Date1999-10-01
Product CodeLYL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Purilens, Inc.. It received FDA 510(k) clearance on 1999-10-01 under 510(k) number K991965. The device is classified under product code LYL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES?

PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES is a medical device that received FDA 510(k) clearance on 1999-10-01. The listed applicant is Purilens, Inc.. The 510(k) number is K991965.

When did PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES receive FDA 510(k) clearance?

PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES received FDA 510(k) clearance on 1999-10-01, under 510(k) number K991965.

Who is the listed applicant for PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES?

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

What is the FDA product code for PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES?

The FDA product code for PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES is LYL.

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.

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Other records listing Purilens, 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.

K002319PURILENS SALINE SOLUTION

Related Devices (Code: LYL)

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.

K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd.K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLCK083757BPZ02 MULTIPURPOSE SOLUTIONBausch & Lomb, Inc.K021699AUTOLENS CLEANING AND DISINFECTING UNITAutolens, Inc.K022687AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTIONCiba Vision CorporationK020802RENUT MULTIPLUS MULLTI-PURPOSE SOLUTIONBausch & Lomb, Incorporated

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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