K250384
- 510(k) number
- K250384
- Device name
- IPL400
- Applicant
- El Global Trade, Ltd. IL
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2025-05-23
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250384.pdf
Official FDA record: K250384
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.