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FDA 510(k)

POLY REJUV

K-Number: K180875 · 2018-09-14

ApplicantMedtek Skincare, LLC
Decision Date2018-09-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLY REJUV is a medical device manufactured by Medtek Skincare, LLC. It received FDA 510(k) clearance on 2018-09-14 under approval number K180875. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY REJUV?

POLY REJUV is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Medtek Skincare, LLC. The 510(k) number is K180875.

When was POLY REJUV approved by the FDA?

POLY REJUV received FDA 510(k) clearance on 2018-09-14, under approval number K180875.

What company makes POLY REJUV?

POLY REJUV is manufactured by Medtek Skincare, LLC.

What is the FDA product code for POLY REJUV?

The FDA product code for POLY REJUV is OHS.

Other Devices by Medtek Skincare, LLC

K183708Poly Clear

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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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