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FDA 510(k)

LENS

K-Number: K821897 · 1983-01-05

ApplicantMortan, Inc.
Decision Date1983-01-05
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENS is the device name listed in this FDA 510(k) record. The listed applicant is Mortan, Inc.. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K821897. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENS?

LENS is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Mortan, Inc.. The 510(k) number is K821897.

When did LENS receive FDA 510(k) clearance?

LENS received FDA 510(k) clearance on 1983-01-05, under 510(k) number K821897.

Who is the listed applicant for LENS?

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

What is the FDA product code for LENS?

The FDA product code for LENS is KYG.

Related PubMed Literature

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.

PMID: 34056520Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.Digital biomarkers ()PMID: 30446241A review of international medical device regulations: Contact lenses and lens care solutions.Contact lens & anterior eye : the journal of the British Contact Lens Association ()

Other records listing Mortan, 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.

K871454MORGAN THERAPEUTIC LENS

Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

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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