K253669
- 510(k) number
- K253669
- Device name
- TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OAP — Laser, Comb, Hair
- Decision date
- 2026-01-23
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253669.pdf
Official FDA record: K253669
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.