FDA 510(k)

UNILENS 38 SOFT ASPHERIC CONTACT LENS

K-Number: K941836 · 1994-07-07

Decision Date1994-07-07

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

UNILENS 38 SOFT ASPHERIC CONTACT LENS 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 1994-07-07 under 510(k) number K941836. 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 UNILENS 38 SOFT ASPHERIC CONTACT LENS?

UNILENS 38 SOFT ASPHERIC CONTACT LENS is a medical device that received FDA 510(k) clearance on 1994-07-07. The listed applicant is Unilens Corp., USA. The 510(k) number is K941836.

When did UNILENS 38 SOFT ASPHERIC CONTACT LENS receive FDA 510(k) clearance?

UNILENS 38 SOFT ASPHERIC CONTACT LENS received FDA 510(k) clearance on 1994-07-07, under 510(k) number K941836.

Who is the listed applicant for UNILENS 38 SOFT ASPHERIC CONTACT LENS?

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 UNILENS 38 SOFT ASPHERIC CONTACT LENS?

The FDA product code for UNILENS 38 SOFT ASPHERIC CONTACT LENS 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,K100456CVUE ADVANCED DEFINITIVE K082393CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS K050743AQUAFLEX 2 (TEFILCON) CONTACT LENS K041608C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS

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Related Devices (Code: LPL)

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.