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FDA 510(k)

PolyDev Soft Contact Lenses

K-Number: K160977 · 2016-07-13

Decision Date2016-07-13
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PolyDev Soft Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Polydev , Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K160977. 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 PolyDev Soft Contact Lenses?

PolyDev Soft Contact Lenses is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Polydev , Ltd.. The 510(k) number is K160977.

When did PolyDev Soft Contact Lenses receive FDA 510(k) clearance?

PolyDev Soft Contact Lenses received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160977.

Who is the listed applicant for PolyDev Soft Contact Lenses?

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

What is the FDA product code for PolyDev Soft Contact Lenses?

The FDA product code for PolyDev Soft Contact Lenses is LPL.

Related Clinical Trials

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.

Other records listing Polydev , Ltd. 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.

Related Devices (Code: LPL)

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.

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.