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FDA 510(k)

GroWell BT Hair Growth System (GW10042)

K-Number: K242619 · 2024-12-02

ApplicantApira Science, Inc.
Decision Date2024-12-02
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GroWell BT Hair Growth System (GW10042) is a medical device manufactured by Apira Science, Inc.. It received FDA 510(k) clearance on 2024-12-02 under approval number K242619. 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 GroWell BT Hair Growth System (GW10042)?

GroWell BT Hair Growth System (GW10042) is a medical device that received FDA 510(k) clearance on 2024-12-02. It is manufactured by Apira Science, Inc.. The 510(k) number is K242619.

When was GroWell BT Hair Growth System (GW10042) approved by the FDA?

GroWell BT Hair Growth System (GW10042) received FDA 510(k) clearance on 2024-12-02, under approval number K242619.

What company makes GroWell BT Hair Growth System (GW10042)?

GroWell BT Hair Growth System (GW10042) is manufactured by Apira Science, Inc..

What is the FDA product code for GroWell BT Hair Growth System (GW10042)?

The FDA product code for GroWell BT Hair Growth System (GW10042) is 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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