FDA 510(k)

CVUE ADVANCED DEFINITIVE

K-Number: K100456 · 2010-10-28

Decision Date2010-10-28

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CVUE ADVANCED DEFINITIVE is the device name listed in this FDA 510(k) record. The listed applicant is Unilens Corp., USA. It received FDA 510(k) clearance on 2010-10-28 under 510(k) number K100456. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVUE ADVANCED DEFINITIVE?

CVUE ADVANCED DEFINITIVE is a medical device that received FDA 510(k) clearance on 2010-10-28. The listed applicant is Unilens Corp., USA. The 510(k) number is K100456.

When did CVUE ADVANCED DEFINITIVE receive FDA 510(k) clearance?

CVUE ADVANCED DEFINITIVE received FDA 510(k) clearance on 2010-10-28, under 510(k) number K100456.

Who is the listed applicant for CVUE ADVANCED DEFINITIVE?

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

What is the FDA product code for CVUE ADVANCED DEFINITIVE?

The FDA product code for CVUE ADVANCED DEFINITIVE is LPL.

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Other records listing Unilens Corp., USA as applicant

K121652CVUE ADVANCED HYDRA VUE K110452SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,K082393CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS K050743AQUAFLEX 2 (TEFILCON) CONTACT LENS K041608C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS K002408AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

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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.