K243040
- 510(k) number
- K243040
- Device name
- LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
- Applicant
- Shenzhen Siken 3D Technology Development Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2024-12-20
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243040.pdf
Official FDA record: K243040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.