Class Class II
Breo Laser Hair Growth Comb (Scalp 3L) (K242620)
Description
Breo Laser Hair Growth Comb (Scalp 3L) by Shenzhen Breo Technology Co., Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242620
Clearance Date2024-11-01
Clearance TypeTraditional
Product CodeOAP
Regulation Number890.5500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242620
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Breo Laser Hair Growth Comb (Scalp 3L) (K242620) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lase... | Hubei Yjt Technology Co.,Ltd | 2023 |
Trace the full predicate network for K242620
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.