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FDA 510(k)

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING

K-Number: K964222 · 1996-12-20

ApplicantPaladin Medical, Inc.
Decision Date1996-12-20
Product CodeLYL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING is the device name listed in this FDA 510(k) record. The listed applicant is Paladin Medical, Inc.. It received FDA 510(k) clearance on 1996-12-20 under 510(k) number K964222. 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 ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING?

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K964222.

When did ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING receive FDA 510(k) clearance?

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING received FDA 510(k) clearance on 1996-12-20, under 510(k) number K964222.

Who is the listed applicant for ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING?

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

What is the FDA product code for ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING?

The FDA product code for ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING is LYL.

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Other records listing Paladin Medical, Inc. as applicant

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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

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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