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FDA 510(k)

iHelmet Hair Growth System

K-Number: K162782 · 2017-04-04

Decision Date2017-04-04
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

iHelmet Hair Growth System is a medical device manufactured by Slinph Technologies Co., Ltd.. It received FDA 510(k) clearance on 2017-04-04 under approval number K162782. 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 iHelmet Hair Growth System?

iHelmet Hair Growth System is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Slinph Technologies Co., Ltd.. The 510(k) number is K162782.

When was iHelmet Hair Growth System approved by the FDA?

iHelmet Hair Growth System received FDA 510(k) clearance on 2017-04-04, under approval number K162782.

What company makes iHelmet Hair Growth System?

iHelmet Hair Growth System is manufactured by Slinph Technologies Co., Ltd..

What is the FDA product code for iHelmet Hair Growth System?

The FDA product code for iHelmet Hair Growth System is OAP.

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Official Source

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