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FDA 510(k)

Hair Growth System

K-Number: K190685 · 2019-07-26

Decision Date2019-07-26
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) 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. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K190685.

When did Hair Growth System receive FDA 510(k) clearance?

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

Who is the listed applicant for Hair Growth System?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Growth System?

The FDA product code for Hair Growth System is OAP.

Other records listing Xuzhou Kernel Medical Equipment Co., 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.

View all 8 devices →

Related Devices (Code: OAP)

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.