FDA 510(k)

Breo Laser Hair Growth Comb (Scalp 3L)

K-Number: K242620 · 2024-11-01

ApplicantShenzhen Breo Technology Co., Ltd.

Decision Date2024-11-01

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Breo Laser Hair Growth Comb (Scalp 3L) is a medical device manufactured by Shenzhen Breo Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under approval number K242620. 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 Breo Laser Hair Growth Comb (Scalp 3L)?

Breo Laser Hair Growth Comb (Scalp 3L) is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Shenzhen Breo Technology Co., Ltd.. The 510(k) number is K242620.

When was Breo Laser Hair Growth Comb (Scalp 3L) approved by the FDA?

Breo Laser Hair Growth Comb (Scalp 3L) received FDA 510(k) clearance on 2024-11-01, under approval number K242620.

What company makes Breo Laser Hair Growth Comb (Scalp 3L)?

Breo Laser Hair Growth Comb (Scalp 3L) is manufactured by Shenzhen Breo Technology Co., Ltd..

What is the FDA product code for Breo Laser Hair Growth Comb (Scalp 3L)?

The FDA product code for Breo Laser Hair Growth Comb (Scalp 3L) is OAP.

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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.