K242620
- 510(k) number
- K242620
- Device name
- Breo Laser Hair Growth Comb (Scalp 3L)
- Applicant
- Shenzhen Breo Technology Co., Ltd. CN
- Product code
- OAP — Laser, Comb, Hair
- Decision date
- 2024-11-01
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242620.pdf
Official FDA record: K242620
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.