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FDA 510(k)

OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES

K-Number: K000998 · 2000-06-05

ApplicantOptisonic, Inc.
Decision Date2000-06-05
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Optisonic, Inc.. It received FDA 510(k) clearance on 2000-06-05 under 510(k) number K000998. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES?

OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Optisonic, Inc.. The 510(k) number is K000998.

When did OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES receive FDA 510(k) clearance?

OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES received FDA 510(k) clearance on 2000-06-05, under 510(k) number K000998.

Who is the listed applicant for OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES?

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

What is the FDA product code for OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES?

The FDA product code for OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES is LPN.

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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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