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FDA 510(k)

Breo Laser Hair Growth Comb (Scalp 3L)

Número K: K242620 · 2024-11-01

RequerenteShenzhen Breo Technology Co., Ltd.
Data da decisão2024-11-01
Código do produtoOAP
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Breo Laser Hair Growth Comb (Scalp 3L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Breo Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242620. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Shenzhen Breo Technology Co., Ltd.. The 510(k) number is K242620.

When did Breo Laser Hair Growth Comb (Scalp 3L) receive FDA 510(k) clearance?

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

Who is the listed applicant for Breo Laser Hair Growth Comb (Scalp 3L)?

The FDA 510(k) record lists Shenzhen Breo Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Dispositivos Relacionados (Código: OAP)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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