K253349
- 510(k) number
- K253349
- Device name
- Hair Regrowth Cap (Model: T-119-HRC)
- Applicant
- Light Tree Ventures Europe B.V. NL
- Product code
- OAP — Laser, Comb, Hair
- Decision date
- 2025-12-24
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253349.pdf
Official FDA record: K253349
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.