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510(k) K242620

Breo Laser Hair Growth Comb (Scalp 3L) by Shenzhen Breo Technology Co., Ltd. — Product Code OAP

K242620 is an FDA 510(k) premarket notification submitted by Shenzhen Breo Technology Co., Ltd. for the device "Breo Laser Hair Growth Comb (Scalp 3L)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
September 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Comb, Hair
Device Class
Class II
Regulation Number
890.5500
Review Panel
SU
Submission Type

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

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FDA data resources