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 a medical device manufactured by Medtek Skincare, LLC. It received FDA 510(k) clearance on 2019-09-17 under approval 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. It is manufactured by Medtek Skincare, LLC. The 510(k) number is K183708.
When was Poly Clear approved by the FDA?
Poly Clear received FDA 510(k) clearance on 2019-09-17, under approval number K183708.
What company makes Poly Clear?
Poly Clear is manufactured by Medtek Skincare, LLC.
What is the FDA product code for Poly Clear?
The FDA product code for Poly Clear is OLP.
Other Devices by Medtek Skincare, LLC
Related Devices (Code: OLP)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.