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FDA 510(k)

Poly Clear

K-Number: K183708 · 2019-09-17

ApplicantMedtek Skincare, LLC
Decision Date2019-09-17
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Poly Clear is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Skincare, LLC. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K183708. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Poly Clear?

Poly Clear is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Medtek Skincare, LLC. The 510(k) number is K183708.

When did Poly Clear receive FDA 510(k) clearance?

Poly Clear received FDA 510(k) clearance on 2019-09-17, under 510(k) number K183708.

Who is the listed applicant for Poly Clear?

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

What is the FDA product code for Poly Clear?

The FDA product code for Poly Clear is OLP.

Other records listing Medtek Skincare, LLC 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.

K180875POLY REJUV

Related Devices (Code: OLP)

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.

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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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