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FDA 510(k)

Hair Growth System

K-Number: K190685 · 2019-07-26

ApplicantXuzhou Kernel Medical Equipment Co., Ltd.
Decision Date2019-07-26
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Growth System is a medical device manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-07-26 under approval number K190685. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hair Growth System?

Hair Growth System is a medical device that received FDA 510(k) clearance on 2019-07-26. It is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K190685.

When was Hair Growth System approved by the FDA?

Hair Growth System received FDA 510(k) clearance on 2019-07-26, under approval number K190685.

What company makes Hair Growth System?

Hair Growth System is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd..

What is the FDA product code for Hair Growth System?

The FDA product code for Hair Growth System is OAP.

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Related PubMed Literature

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Other Devices by Xuzhou Kernel Medical Equipment Co., Ltd.

K160341Colposcope System K181805UV Phototherapy K200971308nm Excimer System K200929Hair Growth System K222751LED Light Therapy Device, KN-7000L K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

View all 7 devices →

Related Devices (Code: OAP)

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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.

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